VNS Therapy® Programmer, Model 3000 v1.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 05425025750429), received between Oct 16, 2018 and Jul 22, 2021 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (49 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  THE TABLET SOFTWARE VERSION WAS CONFIRMED TO BE V1.5.2.1 NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215036 ↗
• MalfunctionMar 19, 2021False Alarm; Application Program Problem: Parameter Calculation Error; False Alarm; Application Program Problem: Parameter Calculation Error

  DURING A PERIODIC PROGRAMING HISTORY REVIEW, HIGH IMPEDANCE AND DEVICE DISABLEMENT WAS OBSERVED FOR THE PATIENT. THE CAUSE OF THE HIGH IMPEDANCE MESSAGE WAS LIKELY A SOFTWARE ERROR ON M3000 V1.5.1.2 SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 V1.5.2.1 SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529039 ↗
• MalfunctionNov 20, 2020Computer Software Problem; Computer Software Problem

  DURING PERIODIC PROGRAMMING HISTORY REVIEW, HIGH IMPEDANCE WAS OBSERVED WHEN V1.5 SOFTWARE WAS USED ON A M102 GENERATOR. SYSTEM DIAGNOSTICS WERE INITIALLY PERFORMED WHICH CAUSED THE FALSE HIGH IMPEDANCE TO BE OBSERVED. NORMAL MODE DIAGNOSTICS WERE PERFORMED SOON AFTER AND SHOWED HIGH LEAD IMPEDANCE BUT DCDC CODE 0. THE IMPEDANCE WAS LIKELY STORED FROM THE PREVIOUS SYSTEM DIAGNOSTICS. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10876763 ↗
• MalfunctionSep 4, 2020Computer Software Problem; Computer Software Problem

  IT WAS IDENTIFIED DURING A PERIODIC REVIEW OF THE PROGRAMMING HISTORY DATABASE THAT A SYSTEM DIAGNOSTIC SHOWED HIGH IMPEDANCE. THE PATIENT'S DEVICE WAS THEN DISABLED. THE SOFTWARE VERSION USED WAS CONFIRMED TO BE (B)(4). IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10493823 ↗
• MalfunctionSep 1, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS OBSERVING IN PROGRAMMING DATA THAT HIGH IMPEDANCE WAS OBSERVED DURING SYSTEM DIAGNOSTICS ON A M102 WITH V1.5 SOFTWARE. IT WAS NOTED THAT THE GENERATOR WAS TEMPORARILY PROGRAMMED OFF AND SYSTEM DIAGNOSTICS WERE REPERFORMED AND NO IMPEDANCE ISSUES WERE OBSERVED. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS GREATER THAN 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 V1.0 AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 V1.5 SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10478254 ↗
• MalfunctionApr 9, 2020Computer Software Problem; Computer Software Problem

  IT WAS IDENTIFIED DURING A PERIODIC REVIEW OF THE PROGRAMMING HISTORY DATABASE THAT A SYSTEM DIAGNOSTIC SHOWS HIGH IMPEDANCE. A SECOND DIAGNOSTIC WAS PERFORMED AFTER THE DEVICE WAS DISABLED AND RESULTED IN OK IMPEDANCE ON THE SAME DAY. THE SOFTWARE VERSION USED WAS CONFIRMED TO BE (B)(4). IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9945921 ↗
• MalfunctionFeb 10, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED VIA A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW THAT THE PATIENT HAD HIGH IMPEDANCE ON TWO SEPARATE PROGRAMMERS. THE HIGH IMPEDANCE WAS OBSERVED WITH (B)(4) SOFTWARE. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. MFR. REPORT # 1644487-2020-00213 CAPTURES THE HIGH IMPEDANCE SEEN WITH PROGRAMMER 1. MFR. REPORT # 1644487-2020-00214 CAPTURES THE HIGH IMPEDANCE SEEN WITH PROGRAMMER 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687833 ↗
• MalfunctionFeb 10, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED VIA A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW THAT THE PATIENT HAD HIGH IMPEDANCE ON TWO SEPARATE PROGRAMMERS. THE HIGH IMPEDANCE WAS OBSERVED WITH (B)(4) SOFTWARE. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. MFR. REPORT # 1644487-2020-00213 CAPTURES THE HIGH IMPEDANCE SEEN WITH PROGRAMMER 1. MFR. REPORT # 1644487-2020-00214 CAPTURES THE HIGH IMPEDANCE SEEN WITH PROGRAMMER 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687754 ↗
• MalfunctionFeb 7, 2020Computer Software Problem; Computer Software Problem

  IT WAS IDENTIFIED DURING A PERIODIC REVIEW OF THE PROGRAMMING HISTORY DATABASE THAT A SYSTEM DIAGNOSTIC SHOWS HIGH IMPEDANCE. A SECOND DIAGNOSTIC WAS PERFORMED AND RESULTED IN OK IMPEDANCE ON THE SAME DAY. SYSTEM DIAGNOSTICS FROM A LATER DATE ALSO SHOWED OK IMPEDANCE. THE SOFTWARE VERSION USED WAS NOTED TO BE (B)(4). IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9683589 ↗
• MalfunctionJan 23, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REVEALED DURING A PERIODIC REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE THAT HIGH IMPEDANCE WAS OBSERVED ON THE PATIENT¿S M102 VNS GENERATOR. IT WAS NOTED THAT THE SOFTWARE WAS A M3000 (B)(4). THE REPRESENTATIVE THEN PROGRAMMED THE OUTPUT CURRENTS OFF AND THE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THIS ISSUE WAS DUPLICATED WITH IN-HOUSE TESTING. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS GREATER THAN 1.00 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO D

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9622594 ↗
• MalfunctionJan 17, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REVEALED DURING A PERIODIC REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE THAT HIGH IMPEDANCE WAS OBSERVED ON THE PATIENT¿S (B)(4) VNS GENERATOR. IT WAS NOTED THAT THE SOFTWARE WAS A M3000 (B)(4). THE REPRESENTATIVE THEN PROGRAMMED THE OUTPUT CURRENTS OFF AND THE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THIS ISSUE WAS DUPLICATED WITH IN-HOUSE TESTING. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS GREATER THAN 1.00 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000(B)(4) AND (B)(4) SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603365 ↗
• MalfunctionNov 22, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED VIA A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW THAT THE PATIENT HAD HIGH IMPEDANCE. THE HIGH IMPEDANCE WAS OBSERVED WITH V1.5 SOFTWARE. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 V1.0 AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 V1.5 SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9364410 ↗
• MalfunctionOct 25, 2019Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE GENERATOR WAS PROPHYLACTICALLY REPLACED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9241388 ↗
• MalfunctionOct 16, 2019Computer Software Problem; Computer Software Problem

  IT WAS FOUND THROUGH PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THE PATIENT'S DEVICE SHOWED A FALSE HIGH IMPEDANCE READING WHEN SYSTEM DIAGNOSTICS WAS PERFORMED. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199278 ↗
• MalfunctionOct 16, 2019Computer Software Problem; Computer Software Problem

  IT WAS REVEALED DURING A PERIODIC REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE THAT HIGH IMPEDANCE WAS OBSERVED ON THE PATIENT¿S M102 VNS GENERATOR. IT WAS NOTED THAT THE SOFTWARE WAS A M3000 (B)(4). THE PHYSICIAN THEN PROGRAMMED THE OUTPUT CURRENTS OFF AND THE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THIS ISSUE WAS DUPLICATED WITH IN-HOUSE TESTING. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS GREATER THAN 1.00 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9198513 ↗
• MalfunctionOct 15, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED VIA A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW THAT THE PATIENT HAD HIGH IMPEDANCE. THE HIGH IMPEDANCE WAS OBSERVED WITH (B)(4) SOFTWARE. THE OUTPUT CURRENTS WERE THEN ALL DISABLED AND THE HIGH IMPEDANCE WAS NO LONGER OBSERVED. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191882 ↗
• MalfunctionOct 7, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  DURING PRODUCT ANALYSIS OF THE GENERATOR AN ADDITIONAL INSTANCE OF A FALSE HIGH IMPEDANCE MESSAGE WAS OBSERVED FOR THE PATIENT'S DEVICE. NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162699 ↗
• MalfunctionSep 24, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A HIGH IMPEDANCE EVENT WAS IDENTIFIED DURING A PERIODIC PROGRAMMING HISTORY REVIEW. HIGH IMPEDANCE DCDC 4 WAS DETECTED WITH MODEL 3000 VERSION 1.5 SOFTWARE WITH SYSTEM DIAGNOSTICS. THE SAME DAY SYSTEM DIAGNOSTICS DETECTED OK IMPEDANCE DCDC-2. ON 1.5 SOFTWARE AFTER THE OUTPUT CURRENTS WERE PROGRAMMED OFF. IT WAS PREVIOUSLY DETERMINED THROUGH IN-HOUSE TESTING THAT, FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1MA, SYSTEM DIAGNOSTICS USING M3000 V1.0 AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 V1.5.2.1 SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. THE CAUSE OF THESE FALSE HIGH IMPEDANCE MESSAGES WAS A SOFTWARE ERROR ON M3000 V1.5.2.1 SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 V1.5.2.1 SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. IT WAS DETERMINED THAT M102/102R SYSTEM DIAGNOSTICS FUNCTIONED AS EXPECTED WHEN THE GENERATOR WAS PROGRAMMED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9107959 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS FOUND THROUGH THE PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THERE WAS A FALSE HIGH IMPEDANCE FOUND WITH SOFTWARE VERSION 1.5. IT WAS VERIFIED THAT THE IMPEDANCE WAS FINE AT THE FOLLOWING CLINIC VISIT WHERE THE DEVICE WAS CHECKED BY SOFTWARE VERSION 1.0. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 V1.5.2.1 SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 V1.5.2.1 SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097865 ↗
• MalfunctionSep 19, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS FOUND THROUGH THE PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THERE WAS A FALSE HIGH IMPEDANCE FOUND WITH SOFTWARE VERSION (B)(4). IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086826 ↗
• MalfunctionSep 17, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS FOUND THROUGH THE PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THERE WAS A FALSE HIGH IMPEDANCE FOUND WITH SOFTWARE VERSION (B)(4) PER THE DATA REVIEWED, THIS CAN BE CONFIRMED TO BE A FALSE HIGH IMPEDANCE AS NORMAL IMPEDANCE WAS OBTAINED AT THE FOLLOWING CLINIC VISIT. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075272 ↗
• MalfunctionSep 5, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE PHYSICIAN THAT AFTER PERFORMING SYSTEM DIAGNOSTICS, HIGH IMPEDANCE WAS REPORTED. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS CHECKED WITH A SOFTWARE VERSION (B)(6). THE PHYSICIAN WAS INSTRUCTED TO BRING THE PATIENT BACK AND TURN THE NORMAL AND MAGNET MODE OUTPUT CURRENT TO 0MA AND RE-RUN SYSTEM DIAGNOSTICS TO VERIFY THIS IS NOT A TRUE HIGH IMPEDANCE. INFORMATION WAS RECEIVED FROM THE PHYSICIAN CONFIRMING THAT THERE WAS FALSE HIGH IMPEDANCE READING DUE TO THE SOFTWARE V (B)(6). CLINIC NOTES RECEIVED INDICATE THAT AFTER PROGRAMMING THE OUTPUT CURRENT TO 0MA, LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. WHEN THE OUTPUT CURRENT WAS PROGRAMMED BACK ON THERE WAS A FALSE HIGH IMPEDANCE READING AGAIN. X-RAY RESULTS WERE PROVIDED INDICATING THAT THE LEAD AND GENERATOR WERE IN PLACE WITH NO NOTED DISRUPTIONS. IT WAS ALSO STATED THAT THERE WAS NO EVIDENCE OF COMPRESSION FRACTURE OR SPONDYLOLISTHESIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8965453 ↗
• MalfunctionAug 20, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED PRE-OPERATIVELY WITH (B)(4) SOFTWARE PRIOR TO A GENERATOR REPLACEMENT DUE TO LOW BATTERY. FOR MODEL 102/102R GENERATORS PROGRAMMED TO OUTPUT CURRENTS > 1 MA , IT WAS OBSERVED THAT SYSTEM DIAGNOSTICS USING M3000 (B)(4) AND M250 SOFTWARE WOULD DISPLAY OK LEAD IMPEDANCE WHILE SYSTEM DIAGNOSTICS USING M3000 (B)(4) SOFTWARE WOULD DISPLAY A FALSE HIGH IMPEDANCE. THE PHYSICIAN ASSESSED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS LIKELY RELATED TO THE SOFTWARE AND THAT THE TREATMENT DECISION WAS NOT EFFECTED, AS THE PATIENT WAS PREVIOUSLY REFERRED FOR GENERATOR REPLACEMENT AND THE LEADS REMAINED INTACT. IT WAS REPORTED THAT THERE WAS NO KNOWN TRAUMA OR MANIPULATION. THE EXPLANT FACILITY DOES NOT RETURN EXPLANTED PRODUCTS, THEREFORE, RETURN OF THE GENERATOR IS NOT EXPECTED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8912214 ↗
• MalfunctionAug 6, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS INITIALLY REPORTED THAT THE PATIENT WAS REFERRED FOR REPLACEMENT DUE TO UNKNOWN REASONS. A CALL WAS LATER RECEIVED FROM THE PHYSICIAN¿S OFFICE INFORMING THAT THE REASON FOR REPLACEMENT DUE TO THE PATIENT¿S HIGH LEAD IMPEDANCE THAT RESOLVED, WHICH THE PHYSICIAN UNDERSTOOD TO BE A RESULT OF BATTERY DEPLETION. THE CLINIC NOTES WERE FURTHER EVALUATED AND IT WAS DISCOVERED THAT THE PHYSICIAN INTERROGATED THE VNS WITH THE OUTPUT CURRENTS PROGRAMMED ON. THIS RESULTED IN "LEAD IMPEDANCE 6600-7700 OHMS.¿ THE PHYSICIAN THEN TURNED THE MAGNET AND THE OUTPUT TO 0MA AND RECHECKED THE DIAGNOSTICS. AT THIS TIME, THE LEAD IMPEDANCE WAS BACK TO NORMAL BETWEEN 4100-5200OHMS. THE PHYSICIAN NOTED THAT THE ONLY EXPLANATION TO THIS EVENT WAS LOW BATTERY WHICH NEEDS TO BE REPLACED. THE BATTERY STATUS OF THE GENERATOR WAS NOT PROVIDED WITHIN THE CLINIC NOTES. FURTHER FOLLOW UP CONFIRMED THAT THE SYSTEM DIAGNOSTICS TESTING WAS PERFORMED USING THE (B)(6) SOFTWARE. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON (B)(6) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH (B)(6) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864177 ↗
• MalfunctionAug 2, 2019Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  HIGH IMPEDANCE WAS DETECTED ON THE PATIENT'S GENERATOR WHEN INTERROGATED WITH V1.5 PROGRAMMING SOFTWARE. THE REPRESENTATIVE PROGRAMMED THE PATIENT'S NORMAL AND MAGNET MODE OUTPUT CURRENTS TO 0MA AND THE LEAD IMPEDANCE WAS THEN WITHIN NORMAL LIMITS. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON (B)(6) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH (B)(6) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856090 ↗

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-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-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-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.