VNS Therapy® Programmer, Model 3000 v1.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05425025750443), received between Dec 12, 2019 and Jan 15, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (30 reports).

30 other recalls cover devices cleared under the same FDA submission (P970003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE DISABLED FOR A MRI AND WHEN RESTARTING THE DEVICE AFTERWARDS, A CURRENT NOT DELIVERED MESSAGE WAS RECEIVED. THE PATIENT WAS THEN SEEN AGAIN, AND A SYSTEM DIAGNOSTICS TEST WAS PERFORMED, AND EVERYTHING WAS WITHIN NORMAL LIMITS. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 V1.6 SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 V1.6 TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. BASED ON THE REPORTED PROGRAMMING SEQUENCE THAT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079738 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANALYSIS OF THE GENERATOR WAS CONDUCTED IN WHICH NO ANOMALIES WERE LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097592 ↗
• MalfunctionMar 18, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A RECENT CONSULT A PATIENT'S DEVICE "DEFAULTED" TO 0MA DURING AN OFFICE VISIT. THIS WAS DETERMINED AFTER A 20+ MINUTE CONSULT WITH THE PATIENT, AND AT THE END OF THE APPOINTMENT A SYSTEM DIAGNOSTIC TEST REVEALED ALL OUTPUTS WENT TO 0MA. THE PHYSICIAN STATED SHE DID NOT MAKE THESE CHANGES HERSELF, BUT SHE DID CHANGE THE PATIENT'S SETTINGS BACK TO WHAT THEY INITIALLY WERE AT THE BEGINNING OF THE APPOINTMENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633490 ↗
• MalfunctionJul 12, 2024Application Program Problem: Dose Calculation Error; Therapeutic or Diagnostic Output Failure; Application Program Problem: Dose Calculation Error; Therapeutic or Diagnostic Output Failure

  THE DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730861 ↗
• MalfunctionOct 12, 2023Application Program Problem: Parameter Calculation Error; Therapeutic or Diagnostic Output Failure; Application Program Problem: Parameter Calculation Error; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT AN ERROR OF HIGH OUTPUT CURRENT WAS DISPLAYED UPON INTERROGATING THE PATIENTS DEVICE. THE ERROR MESSAGE NOTED THAT THE CURRENT COULD NOT BE DELIVERED. IT WAS NOTED THAT AFTER RE-INTERROGATION, THE ERROR WENT AWAY. IT WAS NOTED THAT THIS ERROR OCCURRED RIGHT WHEN DEVICE TURNED FROM NIGHT TO DAYTIME SETTINGS. ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE EVENT OCCURRED FOLLOWING A CHANGE IN DAY/NIGHT SETTINGS WHILE THE GENERATOR WAS STIMULATING AND THAT THE ACTIVE OUTPUT IS DIFFERENT FROM THE ALTERNATIVE OUTPUT CURRENTS FOR DAY AND NIGHT SETTINGS. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927863 ↗
• MalfunctionJan 14, 2022False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT AFTER PROGRAMMING THE PATIENT'S VNS BACK ON FROM 0 MA FOLLOWING AN MRI, A LOW OUTPUT CURRENT ERROR MESSAGE WAS SEEN. THE ERROR MESSAGE RESOLVED AFTER PERFORMING SYSTEM DIAGNOSTICS. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 V1.6 SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 V1.6 TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO 0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. BASED ON THE REPORTED PROGRAMMING SEQUENCE THAT OCCURRED THAT DAY, IT WAS CONSISTENT WITH THE FALSE LOW OUTPUT CURRENT MECHAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260608 ↗
• MalfunctionJun 3, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  THE SOFTWARE VERSION WAS CONFIRMED TO BE M3000 V1.6. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936362 ↗
• MalfunctionMay 6, 2021False Alarm; Failure to Deliver Energy; Physical Resistance/Sticking; False Alarm; Failure to Deliver Energy; Physical Resistance/Sticking

  THE PATIENT WAS SEEN AT A LATER DAT AND LOW OUTPUT CURRENT CONTINUES TO BE WAS OBSERVED. DIAGNOSTICS COULD NOT BE PERFORMED. PATIENT WAS AT 2.0MA AND WAS DECREASED TO 1.875MA. GENERATOR ACCEPTED CHANGES. MAGNET WOULD NOT BE DETECTED. GENERATOR WAS INTERROGATED AGAIN. NO ALERTS AND DIAGNOSTICS WERE PERFORMED. NO ISSUES OBSERVED. MAGNET SWIPE WAS REGISTERED. TROUBLESHOOTING WAS PERFORMED AT AN ADDITIONAL PATIENT VISIT. GENERATOR WAS PROGRAMMED OFF AND THEN BACK ON. LOW OUTPUT CURRENT CONTINUED TO BE OBSERVED. SYSTEM AND MAGNET DIAGNOSTICS WERE ATTEMPTED, BUT COULD NOT BE COMPLETED. GENERATOR RESET WAS PERFORMED AND SUCCESSFUL. SETTINGS WERE NOTED TO BE ABLE TO BE APPLIED. SYSTEM DIAGNOSTICS WAS PERFORMED AND SUBSEQUENTLY LOW IMPEDANCE WAS OBSERVED. THE LOW IMPEDANCE FOLLOWING GENERATOR RESET LIKELY CONFIRMS THE REED SWITCH FAILURE. INTERNAL GENERATOR DATA WAS REVIEWED AND IT WAS DETERMINED THAT THE PATIENT WAS IN A STIM INHIBITED STATE SINCE (B)(6) 2020, INDICATING THAT THE REED SWITCH OF THE GENERATOR WAS CLOSED EVEN THOUGH A MAGNET WAS NOT PRESENT. IT WAS ALSO PREVIOUSLY OBSERVED THAT ERROR CODE 254 WAS REPORTED WHEN ATTEMPTING TO RUN SYSTEM DIAGNOSTICS, WHICH IS ASSOCIATED WITH RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784902 ↗
• MalfunctionFeb 19, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED BY A NURSE THAT WHEN THE NURSE PROGRAMMED A PATIENT BACK ON AFTER IT HAD BEEN DISABLED FOR AN MRI, A LOW OUTPUT CURRENT POP-UP MESSAGE WAS RECEIVED ON HER V1.6 TABLET. IT SAID TO LOWER THE CURRENT AND INCREASE THE PULSE WIDTH. SO, THE NURSE DID THAT AND THEN WENT TO INTERROGATE IN THE SAME SESSION BUT THE SAME MESSAGE POPPED UP.. AFTER EXITING AND STARTING A NEW PROGRAMMING SESSION ON A NEW PROGRAMMER WITH THE PATIENT , THE LOW OUTPUT CURRENT MESSAGE WENT AWAY. THE DATA WAS REVIEWED AND IT WAS OBSERVED THAT THE PATIENT'S GENERATOR WAS PROGRAMMED OFF. THEN SEVERAL HOURS LATER A NEW SESSION WAS STARTED AND THE PATIENT'S VNS WAS PROGRAMMED BACK ON AND NO DIAGNOSTICS WERE RUN. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 V1.6 SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 V1.6 TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348921 ↗
• MalfunctionOct 30, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A REPLACEMENT SURGERY WHEN THE NEW DEVICE WAS INTERROGATED, THE DEVICE SHOWED A LOW OUTPUT CURRENT MESSAGE. ONCE THE DEVICE WAS IMPLANTED AND SYSTEM DIAGNOSTICS WERE PERFORMED, EVERYTHING WAS REPORTED TO BE NORMAL. THE GENERATOR WAS INTERROGATED WITH 1.6 SOFTWARE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 V1.6 SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 V1.6 TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVANT INFORMATION H

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10762799 ↗
• MalfunctionSep 21, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A PATIENT'S NURSE CALLED TO REPORT THAT A LOW OUTPUT STATUS ERROR WAS OBSERVED AFTER THE DEVICE WAS RE-ENABLED TO A NON-ZERO OUTPUT CURRENT FOLLOWING DISABLEMENT FOR MRI. THE NURSE CONFIRMED THAT THE PROGRAMMING SYSTEM WAS RUNNING M3000 (B)(4) SOFTWARE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10564741 ↗
• MalfunctionSep 4, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT'S VNS WAS DISABLED INADVERTENTLY. UPON RE-ENABLING OF THERAPY, A LOW OUTPUT CURRENT MESSAGE WAS SEEN. SYSTEM DIAGNOSTICS WERE PERFORMED AND THE LOW OUTPUT CURRENT RESOLVED, AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 V1.6 SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 V1.6 TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO '0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10494378 ↗
• MalfunctionJul 17, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  LOW OUTPUT CURRENT WAS SEEN AFTER TURNING THE PATIENT'S DEVICE ON AFTER IT WAS DISABLED FOR AN MRI. THE TABLET WAS RESTARTED AND DIAGNOSTICS WERE RUN AND THE RESULTS WERE WITHIN NORMAL LIMITS. THE GENERATOR WAS INTERROGATED WITH (B)(4) SOFTWARE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292422 ↗
• MalfunctionMar 19, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PATIENT WAS DISABLED FOR MRI AND WHEN DEVICE WAS BEING TURNED BACK ON THE SYSTEM SHOWED THAT THE CURRENT WAS NOT DELIVERED. THE PATIENT WAS INTERROGATED AGAIN AND SYSTEM DIAGNOSTICS WERE PERFORMED AND ISSUE RESOLVED. DIAGNOSTICS WERE WITHIN NORMAL LIMITS CONFIRMING NO DEVICE ISSUE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. BASED ON THE REPOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857552 ↗
• MalfunctionFeb 28, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY A NURSE THAT WHEN THE NURSE PROGRAMMED A PATIENT BACK ON AFTER IT HAD BEEN DISABLED FOR AN MRI, A LOW OUTPUT CURRENT POP-UP MESSAGE WAS RECEIVED ON HER (B)(4) TABLET. THE PATIENT STILL PERCEIVED STIMULATION. AFTER EXITING AND STARTING A NEW PROGRAMMING SESSION WITH THE PATIENT AND RUNNING DIAGNOSTICS, THE LOW OUTPUT CURRENT MESSAGE WENT AWAY. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE.. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9771656 ↗
• MalfunctionFeb 25, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A REPLACEMENT SURGERY AFTER THE NEW DEVICE WAS IMPLANTED AND INTERROGATED, THE DEVICE SHOWED A LOW OUTPUT CURRENT MESSAGE. WHEN A SYSTEM DIAGNOSTICS WERE RUN, EVERYTHING WAS REPORTED TO BE NORMAL. THE GENERATOR WAS INTERROGATED WITH (B)(4) SOFTWARE INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751018 ↗
• MalfunctionFeb 21, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS TEMPORARILY DISABLED TO ESTABLISH EFFICACY OF VNS. THE PATIENT BEGAN HAVING MORE SEIZURES WHEN THE DEVICE WAS OFF, THEREFORE IT WAS DECIDED TO TURN BACK ON. WHEN TURNING THE PATIENT'S DEVICE BACK ON, A LOW OUTPUT CURRENT MESSAGE FOR 2.25MA WAS RECEIVED AFTER AN IN SESSION RE-INTERROGATION HAD BEEN PERFORMED. SYSTEM DIAGNOSTICS WAS THEN PERFORMED, CONFIRMING THERE WAS NO DEVICE ISSUE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742030 ↗
• MalfunctionFeb 21, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS TURNED OFF FOR AN MRI AND WHEN TURNING BACK ON, THE PHYSICIAN RECEIVED A LOW OUTPUT CURRENT MESSAGE. THE PHYSICIAN WAS WALKED THOUGH PERFORMING INTERROGATION AND PERFORMING DIAGNOSTICS TEST. EVERYTHING WAS RESOLVED IN THE SESSION. THE PATIENT LEFT THE OFFICE WITH NO ISSUES. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9739523 ↗
• MalfunctionFeb 14, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PHYSICIAN RECEIVED A "CURRENT NOT BEING DELIVERED" MESSAGE THAT WOULD GO AWAY AFTER RE-INTERROGATING THE PATIENT MULTIPLE TIMES. IT WAS STATED THE GENERATORS WERE BEING INTERROGATED AFTER BEING AT ZERO MA FOR AN MRI AND IS WHEN THE "CURRENT NOT DELIVERED" POP-UP MESSAGE WAS BEING SEEN. AFTER A SYSTEM DIAGNOSTICS WAS PERFORMED IN BOTH CASES THE MESSAGE DID NOT APPEAR AND THE CURRENT WAS SEEN TO BE BEING DELIVERED. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711839 ↗
• MalfunctionFeb 14, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PHYSICIAN RECEIVED A "CURRENT NOT BEING DELIVERED" MESSAGE THAT WOULD GO AWAY AFTER RE-INTERROGATING THE PATIENT MULTIPLE TIMES. IT WAS STATED THE GENERATORS WERE BEING INTERROGATED AFTER BEING AT ZERO MA FOR AN MRI AND IS WHEN THE "CURRENT NOT DELIVERED" POP-UP MESSAGE WAS BEING SEEN. AFTER A SYSTEM DIAGNOSTICS WAS PERFORMED IN BOTH CASES THE MESSAGE DID NOT APPEAR AND THE CURRENT WAS SEEN TO BE BEING DELIVERED. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711815 ↗
• MalfunctionJan 31, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN A PATIENT'S GENERATOR WAS DISABLED, AN ERROR SHOWED ON THE SESSION SCREEN NEXT TO THE OUTPUT STATUS INDICATING OUTPUT BEING DELIVERED WAS 2.5 MA ON AN M3000 (B)(4) PROGRAMMING SYSTEM. TWO DAYS LATER, THE PATIENT RETURNED FOR FOLLOW UP WHILE THE DEVICE STILL DISABLED AND A FALSE OUTPUT CURRENT MESSAGE APPEARED ONCE THERAPY WAS RE-ENABLED. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. IT WAS ALSO IDENTIFIED THAT A FALSE LOW OUTPUT CURR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9655984 ↗
• MalfunctionJan 30, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A LOW OUTPUT CURRENT MESSAGE RECEIVED. IT WAS REPORTED THAT THE PATIENT'S OUTPUT CURRENT AND MAGNET CURRENT HAD TO BE LOWERED IN ORDER FOR THE LOW OUTPUT CURRENT MESSAGE NOT TO APPEAR. INTERNAL DATA OF THE GENERATOR WAS REVIEWED AND INDICATED THAT THE GENERATOR WAS PROGRAMMED OFF AND THEN PROGRAMMED BACK ON. A SYSTEM DIAGNOSTIC TEST WAS NOT RECORDED WITHIN THE AVAILABLE INTERNAL DATA OF THE GENERATOR. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT L

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9648459 ↗
• MalfunctionJan 28, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS SEEN THAT THE OUTPUT CURRENT MAY NOT BE GOING THROUGH. THE NURSE KEPT INTERROGATING THE PATIENTS GENERATOR AND RESOLVED THE ISSUE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. BASED ON THE REPORTED PROGRAMMING SEQUENCE THAT OCCURRED THAT DAY, IT WAS CONSISTENT WITH THE FALSE LOW OUTPUT CURRENT MECHANISM DESCRIBED ABOVE. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9637626 ↗
• MalfunctionJan 10, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY A SALES REPRESENTATIVE THAT WHILE CHECKING THE PROGRAMMER OF THE PHYSICIAN, THERE WAS AN ERROR MESSAGE OF POSSIBLE FALSE LOW OUTPUT STATUS FOUND. THE SESSION REPORT WAS PROVIDED INDICATING THE DEVICE WAS BEING TURNED ON AT THE TIME THE ERROR MESSAGE WAS SEEN ON AN M3000 (B)(4) TABLET. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575907 ↗
• MalfunctionJan 3, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT A PHYSICIAN TURNED OFF A PATIENT'S GENERATOR BEFORE AN MRI AND WHEN HE TURNED IT BACK ON, THE PROGRAMMED CURRENT WAS NOT BEING DELIVERED. THIS IS CONSISTENT WITH A FALSE "LOW OUTPUT CURRENT" MESSAGE SEEN IN (B)(4) SOFTWARE. HOWEVER, THE SOFTWARE VERSION WAS NOT CONFIRMED. IT WAS REPORTED THAT THE MESSAGE WAS SEEN MULTIPLE TIMES. AS THIS MESSAGE CAN OCCUR REPEATEDLY UNTIL THE SESSION IS EXITED, IT IS UNCLEAR IF THIS HAPPENED MULTIPLE TIMES ON THE SAME PATIENT OR FOR ANOTHER PATIENT. A REPORT FOR THE EVENT THAT THIS IS IN REFERENCE TO ANOTHER PATIENT WILL BE SUBMITTED UNDER MANUFACTURING REPORT #1644487-2020-00019. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548404 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970003. One submission often covers many models, so check the product and lot details in each record.

• Z-1067-2025 · Jan 3, 2025 · Open, Classified
  Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for
• Z-1068-2025 · Jan 3, 2025 · Open, Classified
  Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" Syste
• Z-1072-2025 · Dec 12, 2024 · Open, Classified
  SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
• Z-0532-2022 · Dec 2, 2021 · Terminated
  Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm e
• Z-0462-2021 · Sep 28, 2020 · Terminated
  VNS Therapy AspireSR Generator
• Z-1563-2020 · Feb 4, 2020 · Open, Classified
  VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
• Z-0561-2020 · Aug 22, 2019 · Terminated
  VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
• Z-1118-2020 · Aug 13, 2019 · Terminated
  VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for
• Z-0346-2020 · Nov 16, 2018 · Open, Classified
  The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stim
• Z-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• Z-0869-2020 · Nov 16, 2018 · Terminated
  Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
• Z-0868-2020 · Nov 16, 2018 · Terminated
  Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
• Z-2572-2018 · Jan 24, 2018 · Terminated
  VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
• Z-0555-2018 · Dec 2, 2017 · Terminated
  VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use a
• Z-2255-2018 · Nov 13, 2017 · Terminated
  VNS Therapy Programmer, Model 3000, v1.0 System

…and 15 more.