VNS Therapy® Programmer, Model 3000 v1.6.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05425025750535), received between Aug 7, 2020 and Apr 4, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Application Program Problem: Parameter Calculation Error; Output below Specifications; Application Program Problem: Parameter Calculation Error; Output below Specifications

  INTERNAL DATA REVIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778619 ↗
• MalfunctionMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS SHOWING ERROR CODE 10: DEVICE DISABLED, AND THAT WHILE INTERROGATING THE DEVICE, THE PATIENT'S GENERATOR SHOWED UP AS THE INCORRECT MODEL AND SERIAL NUMBER, AS WELL AS A SOFTWARE INCOMPATIBILITY MALFUNCTION APPEARING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO INCREASED SEIZURE EPISODES AND EXPERIENCING NEW SEIZURE TYPES. IT IS BELIEVED THIS IS DUE TO A VNS MALFUNCTION. THE PHYSICIAN CONFIRMED THAT NO TRAUMA OR ANYTHING OUT OF THE ORDINARY OCCURRED THAT COULD¿VE CAUSED THE DEVICE TO MALFUNCTION. A GENERATOR RESET WAS ATTEMPTED, ALTHOUGH UNSUCCESSFUL, AS THE SAME ERROR MESSAGE OF SOFTWARE MALFUNCTION WAS SEEN. THE GENERATOR RESET MALFUNCTION, INCREASED SEIZURES AND NEW SEIZURE TYPE ARE REPORTED ON IN MFR. REPORT # 1644487-2025-00243.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542833 ↗
• MalfunctionSep 24, 2024Application Program Problem: Parameter Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Parameter Calculation Error; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GENERATOR WAS RECEIVED INTO THE PRODUCT ANALYSIS LAB. IT WAS REPORTED THAT THE PHYSICIAN THAT HE HAD MISUNDERSTOOD ABOUT THE REMAINING BATTERY. THERE IS NO DEVICE FAILURE ALLEGED BY THE PROVIDER. SESSION REPORTS WERE LATER PROVIDED FROM THE PHYSICIAN'S PROGRAMMING TABLET. IT WAS CONFIRMED THAT THE PHYSICIAN MISUNDERSTOOD THE PATIENT'S BATTERY STATUS - THERE IS NO DEVICE FAILURE. AS CONFIRMED BY THE DATA, THE GENERATOR REACHED 11-25% STATUS ON 2/20/2024, NOT TWO YEARS AGO AS ALLEGED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292710 ↗
• MalfunctionMar 17, 2023Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED FROM THE PHYSICIAN THAT WHEN INTERROGATING THE GENERATOR, A LOW OUTPUT WAS OBSERVED. THE TM REVIEWED THE SESSION REPORT AND THE OUTPUT CURRENT WAS ACTUALLY SEEN TO BE AT THE VALUE IT WAS PROGRAMMED. TABLET DATA WAS INCLUDED WITH THE REPORT FOR REVIEW. INTERNAL INVESTIGATION REVEALED THAT THE FALSE LOW OUTPUT CURRENT WAS DUE TO COMMUNICATION BEING DISRUPTED WHILE PERFORMING A DIAGNOSTICS TEST ON THE GENERATOR. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE SOFTWARE/FIRMWARE, AS THESE COMMUNICATION DISRUPTIONS CAUSE DELAYS IN THE DIAGNOSTIC SEQUENCE RESULTING IN THE FALSE LOW OUTPUT CURRENT WARNING MESSAGE; NO MALFUNCTION OCCURRED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565104 ↗
• MalfunctionFeb 9, 2023Application Program Problem: Parameter Calculation Error; Output below Specifications; Application Program Problem: Parameter Calculation Error; Output below Specifications

  IT WAS REPORTED THAT A PHYSICIAN WAS TRYING TO PROGRAM A PATIENT'S DAY/NIGHT MODE AND CONTINUALLY RECEIVED AN ERROR MESSAGE STATING, "15 MINUTE TEST INTERRUPTED." A LOW OUTPUT WARNING MESSAGE WAS ALSO SEEN. THE WAND CONNECTION TROUBLESHOOTING WAS PERFORMED, BUT THE ERROR MESSAGE WAS STILL PRESENT. THEN THE TABLET WAS RESET AND DIAGNOSTICS WERE RAN. RESULTS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN ATTEMPTED TO ENABLE DAY/NIGHT MODE AGAIN, AND THE SAME ERROR MESSAGE WAS SEEN. HOWEVER, THE SCHEDULE WAS ENABLED AND THE PARAMETERS WERE SET AS PHYSICIAN HAD INTENDED. PHYSICIAN LEFT THE SESSION AND WAS ABLE TO CHANGE NORMAL PARAMETERS SUCCESSFULLY. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334191 ↗
• MalfunctionFeb 2, 2023False Alarm; Output below Specifications; False Alarm; Output below Specifications

  A REVIEW OF THE DATA FILES ASSOCIATED WITH THIS DEVICE REVEALED THAT THE ISSUE OF LOW OUTPUT CURRENT IS RELATED TO AN INCOMPLETE MAGNET MODE DIAGNOSTIC TEST, IN THAT THE MAGNET SWIPE WAS INCOMPLETE. THERE IS ALSO NO PERFORMANCE ISSUE WITH THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284536 ↗
• MalfunctionDec 12, 2022Application Program Problem: Parameter Calculation Error; Low impedance; Application Program Problem: Parameter Calculation Error; Low impedance

  REVIEWING LOG FILES, IT WAS FOUND THAT DURING THE PROGRAMMING EVENT THAT OCCURRED RIGHT AFTER ENABLING DAY/NIGHT MODE, THE PRONE POSITION DETECTION WAS ENABLED AND THE LOW HEART RATE THRESHOLD WAS CHANGED TO 50 BPM. IT IS KNOWN THAT IF ANY SETTINGS NOT RELATED TO STIMULATION PARAMETERS (CURRENT, ON TIME, OFF TIME, ETC) ARE CHANGED, THE PROGRAMMER WILL COMMAND THE IPG TO STOP THE TEMPORARY TEST AND THE IPG WILL RE-ENTER DAY MODE SETTINGS. WHEN A SYSTEM DIAGNOSTICS IS PERFORMED, THE PROGRAMMER ERRANTLY COMPARES THE DIAGNOSTICS RESULTS (WHICH WERE RUN WITH DAYTIME STIM PARAMETERS) AGAINST NIGHTTIME SETTINGS EVEN THOUGH IPG IS IN DAY MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963529 ↗
• MalfunctionNov 23, 2022Application Program Problem: Parameter Calculation Error; Output below Specifications; Application Program Problem: Parameter Calculation Error; Output below Specifications

  DURING A BATTERY REPLACEMENT WHILE TRYING TO PROGRAM THE NEW GENERATOR TO THE OLD SETTINGS, A LOW OUTPUT CURRENT ERROR MESSAGE WAS RECEIVED. THEY THEN LOWERED THE SETTINGS AND THE ERROR RESOLVED AND ALL VALUES WERE WITHIN NORMAL LIMITS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852128 ↗
• MalfunctionMay 26, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS OBSERVED THAT LOW OUTPUT CURRENT WAS SEEN WHEN A PATIENT'S GENERATOR WAS PROGRAMMED OFF AND BACK ON AFTER A MRI. 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, IT WAS CONSISTENT WITH THE FALSE LOW OUTPUT CURRENT MECHANISM DESCRIBED ABOVE. THEREFORE, THE PATIENT'S GENERATOR IS EXPECTED TO BE ABLE TO DELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885337 ↗
• MalfunctionMay 14, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  PATIENT WAS REPORTED TO HAVE HAD THEIR GENERATOR PROGRAMMED OFF FOR AN MRI. THE PATIENT WAS LATER PROGRAMMED BACK ON AND A RED TRIANGLE WAS OBSERVED IN THE SESSION REPORT INDICATING LOW OUTPUT CURRENT. 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, IT WAS CONSISTENT WITH THE FALSE LOW OUTPUT CURRENT MECHANISM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825918 ↗
• MalfunctionApr 23, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT THE PATIENT'S VNS WAS TURNED OFF FOR A MRI AND WHEN SETTINGS WERE RESET, THERE WAS AN ERROR INDICATING LOW OUTPUT CURRENT. SYSTEM DIAGNOSTIC RESULTS WERE NORMAL. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11718450 ↗
• MalfunctionApr 13, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  MEDICAL PROFESSIONAL REPORTED THAT WHILE REVIEWING PROGRAMMING SESSION REPORTS IT WAS OBSERVED A PATIENT HAD LOW OUTPUT CURRENT. THE PATIENT GENERATOR WAS NOTED TO HAVE BEEN DISABLED FOR SURGERY AND RE-PROGRAMMED ON FOR THERAPY. LOW OUTPUT CURRENT OCCURRED WHEN THE PATIENT WAS PROGRAMMED BACK ON. MEDICAL PROFESSIONAL WAS CONFIRMED TO BE USING (B)(4) SOFTWARE. IMPEDANCE WAS NOTED TO BE OKAY AND BATTERY STATUS WAS 11-25%. PATIENT WAS NOT ABLE TO HAVE SYSTEM DIAGNOSTICS RE-PERFORMED PRIOR TO LEAVING OFFICE; HOWEVER, NO GENERATOR ISSUES ARE SUSPECTED AS THIS IS A KNOWN EVENT WHICH CAN OCCUR FOR (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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656365 ↗
• MalfunctionMar 25, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT THE PATIENTS DEVICE WAS TURNED OFF FOR A SURGERY, AND WHEN IT WAS TURNED BACK ON A UNDELIVERABLE OUTPUT CURRENT WARNING WAS RECEIVED. IT WAS CONFIRMED THAT (B)(4) SOFTWARE WAS BEING USED. AFTER RE-INTERROGATING, THE ISSUE RESOLVED AND DIAGNOSTICS WERE NORMAL. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN (B)(4) SOFTWARE PROGRAMS A (B)(4) GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A (B)(4) GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO 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 THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567631 ↗
• MalfunctionFeb 23, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED WHEN PROGRAMMING ON A PATIENT'S DEVICE FROM 0MA, LOW OUTPUT CURRENT OF 1MA WAS REPORTED. LEAD IMPEDANCE AND BATTERY STATUS WERE REPORTED TO BE OKAY. THE PATIENT HAD BEEN DISABLED FOR AN MRI. 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 CURR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367243 ↗
• MalfunctionFeb 1, 2021Computer 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 A MRI, AND WHEN IT WAS TURNED BACK ON A "UNDELIVERABLE OUTPUT CURRENT" WARNING WAS RECEIVED. IT WAS CONFIRMED THAT (B)(4) SOFTWARE WAS BEING USED. AFTER RE-INTERROGATING AND PERFORMING SYSTEM DIAGNOSTICS, THE ISSUE RESOLVED AND DIAGNOSTICS WERE NORMAL. 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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11258708 ↗
• MalfunctionDec 21, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT WAS REPORTED TO HAVE HAD THEIR GENERATOR PROGRAMMED OFF FOR AN MRI. WHEN THE PATIENT WAS INTERROGATED AND PROGRAMMED BACK ON, LOW OUTPUT CURRENT WAS OBSERVED. IT WAS NOTED THAT THE PATIENT WAS RE-INTERROGATED AND HAD SYSTEM DIAGNOSTICS PERFORMED, THE DEVICE WAS OBSERVED TO BE FUNCTIONING PROPERLY. 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 RE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11047645 ↗
• MalfunctionNov 17, 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 HAD JUST RECEIVED AN MRI AND THAT WHEN TRYING TO RE-ENABLE THE PATIENT'S THERAPY AN UNDELIVERABLE OUTPUT CURRENT MESSAGE WAS SEEN. IT WAS INDICATED THAT AFTER A SYSTEM DIAGNOSTIC TEST WAS PERFORMED, THE LOW OUTPUT CURRENT MESSAGE RESOLVED. 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 OCCUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10852139 ↗
• MalfunctionNov 13, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  AFTER THE PATIENTS REPLACEMENT SURGERY, THE DEVICE WAS TURNED OFF AND ON A FEW TIMES, AND A CURRENT NOT DELIVERED MESSAGE WAS RECEIVED AT ONE POINT. 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 WERENT 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. THEREFORE, THE PATIENT'S GENERAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10839770 ↗
• MalfunctionNov 13, 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 GENERATOR WAS OBSERVED TO HAVE CURRENT NOT DELIVERED AFTER BEING PROGRAMMED OFF AND BACK ON FOR AN MRI. A DIFFERENT PROGRAMMING SYSTEM WAS USED AND THE ERROR MESSAGE WAS NOT OBSERVED. IT WAS NOTED THAT THE TREATMENT DECISION WAS NOT CHANGE DUE TO THE LOW OUTPUT CURRENT OBSERVED. 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 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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10839544 ↗
• MalfunctionNov 6, 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 HAD JUST RECEIVED AN MRI AND THAT WHEN TRYING TO RE-ENABLE THE PATIENT'S THERAPY AN UNDELIVERABLE OUTPUT CURRENT MESSAGE WAS SEEN. IT WAS INDICATED THAT AFTER THE MESSAGE WAS SEEN THE PHYSICIAN RESTARTED THEIR TABLET, AND THAT UPON RE-INTERROGATION THE UNDELIVERABLE OUTPUT CURRENT MESSAGE WAS NOT OBSERVED. 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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10800860 ↗
• MalfunctionOct 6, 2020Computer Software Problem; Computer Software Problem

  THE SALES REPRESENTATIVE REPORTED THAT SHE WAS TRYING TO INTERROGATE THE PATIENT IN CLINIC AND WAS RECEIVING LOTS OF ERROR MESSAGES, AND WHEN SHE WAS FINALLY ABLE TO INTERROGATE SHE INCREASED OUTPUT CURRENT FROM 0.75 MA TO 1MA. DIAGNOSTICS WERE NORMAL. SHE THEN EXITED THE SESSION AND TRIED TO RE-INTERROGATE BUT AGAIN RECEIVED ERROR MESSAGES. SHE SWITCHED TABLETS AND WAS ABLE TO INTERROGATE, HOWEVER IT SHOWED THE LOW OUTPUT CURRENT SYMBOL AND NOTED ONLY 0.75MA BEING DELIVERED. IMPEDANCE WAS OK, 2702 OHMS. THE DEVICE WAS SHOWN TO BE PROGRAMMED TO 1MA. SHE TRIED RUNNING DIAGNOSTICS BUT THE PATIENT STARTED TO COUGH SO SHE ENDED THE DIAGNOSTICS. SHE NOTED THAT IT WAS NO LONGER SHOWING LOW OUTPUT CURRENT AND ALL FOLLOWING TESTS WERE NORMAL. REVIEW OF THE DATA REVEALED THAT THE EVENT WAS LIKELY RELATED TO A PARTIAL PROGRAMMING EVENT. IF THE PARTIAL PROGRAMMING EVENT HAD CHANGED OUTPUT CURRENT, BUT THE GENERATOR DID NOT RECEIVE THE STARTSTIM COMMAND BEFORE THE PROGRAMMING EVENT FAILED (TELLING IT TO START STIMULATION), A LOW OUTPUT CURRENT MESSAGE CAN BE RECEIVED IF THE USER CHOOSES TO NOT RETRY THE PROGRAMMING EVENT AND INTERROGATES AGAIN BEFORE THE OFF TIME EXPIRES. THIS IS BECAUSE THE S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10637681 ↗
• MalfunctionSep 25, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT PRESENTED TO HAVE THEIR GENERATOR TURNED ON AFTER BEING DISABLED FOR AN MRI. WHEN THE GENERATOR WAS PROGRAMMED ON, A WARNING MESSAGE WAS RECEIVED STATING THE CURRENT WAS NOT DELIVERED. THE GENERATOR WAS INTERROGATED WITH A PROGRAMMING SYSTEM USING (B)(4) SOFTWARE. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN (B)(4) 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 62;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 OCCURRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10586747 ↗
• MalfunctionSep 25, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  AN ERROR MESSAGE WAS RECEIVED STATING THE OUTPUT CURRENT MAY NOT BE DELIVERABLE DUE TO IMPEDANCE OR BATTERY VOLTAGE. THE MESSAGE WAS SEEN WHEN THE PATIENT'S GENERATOR WAS BEING PROGRAMMED BACK ON AFTER BEING DISABLED. THE VNS WAS DISABLED DUE TO TESTING BEING DONE ON THE PATIENT'S OTHER IMPLANTED DEVICE. INFORMATION WAS RECEIVED STATING THE PROGRAMMING SYSTEM WAS USING 1.6 SOFTWARE. THE MESSAGE WAS NOTED TO RESOLVE BY TURNING OFF THE TABLET AND RE-INTERROGATING OR RUNNING 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 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 FUNCTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10586479 ↗
• MalfunctionSep 18, 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 HAD THE VNS TURNED OFF BEFORE A MRI AND THE SESSION REPORT SHOWED NORMAL DIAGNOSTICS, ALL OUTPUT CURRENTS WERE OFF. WHEN THE DEVICE WAS TURNED BACK ON, THE DEVICE SHOWED A LOW OUTPUT CURRENT WARNING, OUTPUT STATUS WAS 2.25 MA WITH A RED WARNING SIGN, AND IMPEDANCE WAS OK. THE DEVICE WAS LATER RE-INTERROGATED AND NO ERRORS WERE PRESENT. 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 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 AR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10554902 ↗
• MalfunctionSep 17, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT PRESENTED TO HAVE THEIR GENERATOR TURNED ON AFTER BEING DISABLED FOR AN MRI. WHEN THE GENERATOR WAS PROGRAMMED ON, A WARNING MESSAGE WAS RECEIVED STATING THE CURRENT WAS NOT DELIVERED. SYSTEM DIAGNOSTICS WERE RUN AND THE ERROR MESSAGE CLEARED AND THE DEVICE WAS OPERATING NORMALLY. THE GENERATOR WAS INTERROGATED WITH A PROGRAMMING SYSTEM USING 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 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 WERENT 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 A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10550351 ↗

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-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-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-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-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-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-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-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.