VNS Therapy® Programmer, Model 3000 v1.0.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05425025750481), received between Feb 16, 2018 and Jun 22, 2023 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Application Program Problem: Dose Calculation Error; Therapeutic or Diagnostic Output Failure; Application Program Problem: Dose Calculation Error; Therapeutic or Diagnostic Output Failure

  DURING A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW A FAULTED DIAGNOSTIC EVENT WAS LOCATED ON 4/14/2014 (THIS DID NOT RESULT IN SPONTANEOUS CHANGE IN SETTINGS). THE PATIENT WAS INTERROGATED BY A NEW HP TABLET 5CD820D6BN ON (B)(6) 2021 (PREVIOUSLY SEEN TO BE INTERROGATED BY MOTION TABLET 00390568). THE SETTINGS WERE SEEN TO BE "CHANGED" TO 60 MIN OFF TIME AND MAGNET OUTPUT CHANGED TO 1.5 MA. BASED ON THE AVAILABLE DATA THERE IS NO FAULT OCCURRING ON ANY OF THE DEVICES. WHAT LIKELY HAD CAUSED THIS;CHANGE IN SETTINGS; IS A SETTING CHANGE THAT OCCURRED ON ANOTHER TABLET (NOT INCLUDED IN THIS DATA SET). THERE ARE NO OTHER DIAGNOSTIC EVENT RECORDED OUTSIDE OF THIS. THERE IS NO DEFINITIVE WAY TO PROVE THAT NO FAULT IS OCCURRING; THEREFORE THIS EVENT WILL BE CAPTURED AS A MALFUNCTION, UNTIL PROVED OTHERWISE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187298 ↗
• MalfunctionAug 19, 2022Failure to Deliver Energy; Output below Specifications; Failure to Deliver Energy; Output below Specifications

  IT WAS REPORTED THAT A GENERATOR HAD DISABLED OUTPUT ERROR SEEN DURING A PATIENT'S INITIAL IMPLANT SURGERY. REPRESENTATIVE HAD ISSUES WITH THE WAND BATTERIES DURING THE SURGERY AND SUSPECTED THIS MAY HAVE CAUSED THE ISSUE. REPRESENTATIVE CHANGED THE BATTERIES AND RE-INTERROGATED THE DEVICE THREE SUCCESSFUL TIMES WITHOUT THE "OUTPUT CURRENT: DISABLED" MESSAGE APPEARING. AFTER REVIEW OF THE SITUATION AND THE THREE SUCCESSFUL INTERROGATIONS AND SYSTEM DIAGNOSTICS WITHIN NORMAL LIMITS THE SURGEON CONTINUED AND CONCLUDED THE PROCEDURE. INTERNAL DATA FROM THE GENERATOR WAS REVIEWED. THE CREATED DECODER SHOWS THE GENERATOR WAS INTERROGATED IN A STIM STOPPED STATE. TABLET SOFTWARE VERSION WAS FOUND TO BE V1.6.1.9. COMMUNICATION LOGS WERE REVIEWED. A DIFFERENT GENERATOR WAS INTERROGATED PRIOR TO THE NEW ONE. THE FIRST GENERATOR WAS IN DAY/NIGHT MODE. WITHOUT POWER CYCLING THE TABLET, THE SECOND GENERATOR WAS INTERROGATED. THE ROOT CAUSE OF THE GENERATOR DISABLEMENT WAS DUE TO A KNOWN SOFTWARE ISSUE ON VERSION 1.6.1 THAT WAS IDENTIFIED FOLLOWING A SPECIFIC SEQUENCE OF EVENTS. FOR THIS EVENT TO OCCUR, A MODEL 1000 DEVICE MUST BE INTERROGATED WITH AN AFFECTED MODEL 3000 DEVICE, THEN DAY-NIGHT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262694 ↗
• MalfunctionMar 29, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  PHYSICIAN REPORTED THAT WHILE INCREASING THE PATIENT'S NIGHT OUTPUT CURRENT, A MESSAGE WAS RECEIVED NOTING THAT OUTPUT CURRENT IS NOT BEING DELIVERED. LEAD IMPEDANCE AND BATTERY STATUS WERE WITHIN NORMAL LIMITS. INTERNAL DATA FROM THE PATIENT¿S GENERATOR WAS REVIEWED. THE PEAK OUTPUT CURRENT DELIVERED FOR THE GENERATOR WAS EQUIVALENT TO THE DAYTIME VALUE PROGRAMMED. GENERATOR DEVICE HISTORY RECORD WAS REVIEWED; NO UNRESOLVED NON-CONFORMANCES WERE IDENTIFIED, AND THE GENERATOR PASSED ALL QUALITY CONTROL SPECIFICATIONS PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586360 ↗
• InjuryJan 11, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING THE LAST CLINIC VISIT, THE PATIENT'S SETTINGS WERE NOTED TO HAVE RESET TO DEFAULT SETTINGS. SINCE THE LAST VISIT, THE PATIENT BEGAN HAVING WORSENING SEIZURES AND IS NOW HAVING DROPS IN SEIZURES, MORE FREQUENT/LONGER DAYTIME SEIZURES AND NIGHTLY NOCTURNAL SEIZURES. THE PATIENT'S SETTINGS WERE ABLE TO BE TITRATED BACK UP CLOSE TO WHAT THEY PREVIOUSLY WERE. M102 GENERATORS CHANGE SETTINGS FROM PROGRAMMED SETTINGS TO DIAGNOSTICS SETTINGS BACK TO PROGRAMMED SETTINGS TO RUN SYSTEM DIAGNOSTICS; THEREFORE, WHEN THE DIAGNOSTICS WERE INTERRUPTED, THE SETTINGS WERE LEFT AT THE DIAGNOSTICS SETTINGS. THE PHYSICIAN DID NOT RUN A FINAL INTERROGATION AS RECOMMENDED PER LABELING SO THIS SETTINGS CHANGE WAS NOT FOUND AND CORRECTED UNTIL THE NEXT APPOINTMENT WHEN THEY WERE FOUND TO HAVE RESET. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 11147484 ↗
• MalfunctionSep 21, 2020Computer Software Problem; Computer Software Problem

  THE PHYSICIAN TRIED INTERROGATING THE PATIENTS GENERATOR AND RECEIVED ERROR CODE 254, LEAD IMPEDANCE LOW AND GENERATOR DISABLED. PATIENTS GENERATOR WAS EXPLANTED. THE EXPLANTED PRODUCT HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. INVESTIGATION INTO THE LOG FILES INDICATED THAT THE PATIENTS GENERATOR WAS IN A STOP STATE MODE AND WAS INTERROGATED WITH A VERSION (B)(6) SOFTWARE. THE SOFTWARE WILL GIVE ERROR CODE 254 IF THE GENERATOR IS IN STOP STATE WITH NO ASSOCIATED REBOOT. AT 2:01PM THE IPG REJECTED AN OVERRIDE COMMAND. THE PRIOR IPG INTERROGATED BY THE PROGRAMMER WAS IN DAY/NIGHT MODE. FOR THIS EVENT TO OCCUR, A MODEL 1000 DEVICE MUST BE INTERROGATED WITH AN AFFECTED MODEL 3000 DEVICE, THEN DAY-NIGHT MODE IS ENABLED ON THAT MODEL 1000 GENERATOR AND THE SESSION IS ENDED WITH OUT POWERING OFF THE TABLET. NEXT A SECOND MODEL 1000 DEVICE IS INTERROGATED USING THE SAME MODEL 3000 PROGRAMMER AND HAS GUIDED MODE ENABLED. STEP-UP OR STEP-DOWN PROGRAM OPERATION IS ATTEMPTED WHICH PLACES THE GENERATOR IN STOP STATE. THE USER WILL BE PRESENTED WITH A PROGRAMMING ERROR AND PROGRAMMING WILL FAIL AND FORCE THE USER TO RE-INTERROGATE. IF RE-INT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10561331 ↗
• MalfunctionSep 14, 2020Computer Software Problem; Computer Software Problem

  DURING A PERIODIC REVIEW OF THE PROGRAMMING HISTORY DATABASE, A HIGH IMPEDANCE EVENT WAS IDENTIFIED. IT WAS NOTED THAT THE PROGRAMMING SYSTEM WAS RUNNING SOFTWARE VERSION 1.5. 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 ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10528581 ↗
• MalfunctionApr 6, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT AFTER PROGRAMMING PATIENT FOR GUIDED MODE AND SETTING THE PATIENT ON STEP 2, THE SET VALUES OF THE NORMAL STIMULATION, MAGNET MODE AND AUTOSTIM DID NOT LINE UP WITH THE CUSTOM PROTOCOL STEP VALUES FOR STIMULATION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9928350 ↗
• MalfunctionFeb 7, 2020Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  PHYSICIAN REPORTED THAT WHILE INCREASING BOTH OF THE PATIENT'S DAY AND NIGHT OUTPUT CURRENT, A MESSAGE WAS RECEIVED NOTING THAT OUTPUT CURRENT IS NOT BEING DELIVERED. LEAD IMPEDANCE AND BATTERY STATUS WERE WITHIN NORMAL LIMITS. PER OHM'S LAW CALCULATION THE GENERATOR SHOULD BE ABLE TO DELIVER THE PROGRAMMED OUTPUT CURRENT. INTERNAL DATA FROM THE PATIENT¿S GENERATOR WAS REVIEWED. THE PEAK OUTPUT CURRENT DELIVERED FOR THE GENERATOR WAS EQUIVALENT TO THE DAYTIME VALUE PROGRAMMED. TWO DIAGNOSTICS TESTS WERE PERFORMED. GENERATOR DEVICE HISTORY RECORD WAS REVIEWED; NO UNRESOLVED NON-CONFORMANCES WERE IDENTIFIED, AND THE GENERATOR PASSED ALL QUALITY CONTROL SPECIFICATIONS PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684035 ↗
• MalfunctionFeb 7, 2020Computer Software Problem; Energy Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Energy Output Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT'S OUTPUT CURRENTS WERE INCREASED FOR BOTH DAY AND NIGHT MODE. DIAGNOSTICS WERE PERFORMED IMMEDIATELY AFTERWARD AND AN "OUTPUT CURRENT NOT DELIVERED" MESSAGE WAS RECEIVED. LEAD IMPEDANCE AND BATTERY STATUS WERE WITHIN NORMAL LIMITS. PER OHM'S LAW CALCULATION THE GENERATOR SHOULD BE ABLE TO DELIVER THE PROGRAMMED OUTPUT CURRENT. TABLET DATA WAS REVIEWED. THE PEAK OUTPUT CURRENT DELIVERED EQUIVALENT TO THE VALUE FOR DAYTIME SETTINGS, BUT WAS LOWER THAN THE PROGRAMMED NIGHTTIME SETTINGS. THE DIAGNOSTICS WERE PERFORMED 2 MINUTES AFTER THE SETTINGS CHANGE, WHICH WOULD BE DURING THE PERIOD OF TIME IN WHICH THE GENERATOR WAS RUNNING NIGHTTIME SETTINGS. THERE WERE NO NOTED REBOOTS OR THERAPY STATUS FLAGS. GENERATOR DEVICE HISTORY RECORD WAS REVIEWED; NO UNRESOLVED NON-CONFORMANCES WERE IDENTIFIED, AND THE GENERATOR PASSED ALL QUALITY CONTROL SPECIFICATIONS PRIOR TO DISTRIBUTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9683936 ↗
• MalfunctionJan 10, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT HIGH IMPEDANCE AND EOS-YES END OF LIFE MESSAGE WAS UNEXPECTEDLY SEEN UPON INTERROGATION. THE HIGH IMPEDANCE AND EOS-YES CONDITION RESOLVED WHEN SYSTEMS DIAGNOSTICS WERE PERFORMED ON THE GENERATOR THE DIAGNOSTICS SHOWED THAT THE GENERATOR WAS FUNCTIONING WITHIN NORMAL LIMITS. UPON DATA REVIEW, IT WAS DETERMINED THAT SOME RESPONSE PACKETS OF DATA RECEIVED FROM THE GENERATOR VIA THE WAND WERE DUPLICATED AND/OR RECEIVED OUT OF SEQUENCE COMPARED TO THE PRIOR COMMAND PACKETS FROM THE PROGRAMMER. THIS RESULTED IN THE SOFTWARE INCORRECTLY CALCULATING SEVERAL VALUES THAT WERE RECEIVED TO DISPLAY. NOTE THAT THE ACTUAL DATA PROGRAMMED INTO THE GENERATOR WAS CORRECT AND THE ISSUE RESOLVED UPON RE-INTERROGATION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9573657 ↗
• InjuryJul 5, 2019Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE PATIENT'S INCREASED SEIZURE RATE WAS WORSE THAN THEIR PRE-VNS SEIZURE RATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 8764707 ↗
• MalfunctionMar 8, 2019Computer Software Problem; Computer Software Problem

  IT WAS REVEALED DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, AN INTERROGATION RESULTED IN ABNORMAL PARAMETERS, INCLUDING AN IMPOSSIBLE PULSE WIDTH VALUE AND AUTOSTIMULATION ON TIME AS WELL AS DISABLED OUTPUT CURRENTS. UPON REINTERROGATION, THE PARAMETERS RESOLVED. IMPEDANCE WAS WITHIN NORMAL LIMITS UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT SOME RESPONSE PACKETS OF DATA RECEIVED FROM THE GENERATOR VIA THE WAND WERE DUPLICATED AND/OR RECEIVED OUT OF SEQUENCE COMPARED TO THE PRIOR COMMAND PACKETS FROM THE PROGRAMMER. THIS RESULTED IN THE SOFTWARE INCORRECTLY CALCULATING SEVERAL VALUES THAT WERE RECEIVED TO DISPLAY. NOTE THAT THE ACTUAL DATA PROGRAMMED INTO THE GENERATOR WAS CORRECT AND THE ISSUE RESOLVED UPON RE-INTERROGATION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405725 ↗
• MalfunctionMar 8, 2019Computer Software Problem; Computer Software Problem

  IT WAS REVEALED DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, AN INTERROGATION RESULTED IN ABNORMAL PARAMETERS, INCLUDING AN IMPOSSIBLE PULSE WIDTH VALUE AND AUTOSTIMULATION ON TIME AS WELL AS DISABLED OUTPUT CURRENTS. UPON REINTERROGATION, THE PARAMETERS RESOLVED. DIAGNOSTICS WERE WITHIN NORMAL LIMITS UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT SOME RESPONSE PACKETS OF DATA RECEIVED FROM THE GENERATOR VIA THE WAND WERE DUPLICATED AND/OR RECEIVED OUT OF SEQUENCE COMPARED TO THE PRIOR COMMAND PACKETS FROM THE PROGRAMMER. THIS RESULTED IN THE SOFTWARE INCORRECTLY CALCULATING SEVERAL VALUES THAT WERE RECEIVED TO DISPLAY. NOTE THAT THE ACTUAL DATA PROGRAMMED INTO THE GENERATOR WAS CORRECT AND THE ISSUE RESOLVED UPON RE-INTERROGATION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405605 ↗
• MalfunctionMar 8, 2019Computer Software Problem; Computer Software Problem

  IT WAS REVEALED DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, A FALSE ABNORMAL DIAGNOSTICS MESSAGE WAS OBSERVED ON A DIAGNOSTICS TEST PERFORMED MID-SESSION (I.E. NOT UPON INITIAL INTERROGATION). THE DIAGNOSTICS WERE WITHIN NORMAL LIMITS WITH SYSTEM DIAGNOSTICS PERFORMED WITHIN THE NEXT FEW MINUTES. THE ABNORMAL DIAGNOSTICS FALSELY INDICATED LOW OUTPUT CURRENT, HIGH IMPEDANCE, AND LOW BATTERY. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT SOME RESPONSE PACKETS OF DATA RECEIVED FROM THE GENERATOR VIA THE WAND WERE DUPLICATED AND/OR RECEIVED OUT OF SEQUENCE COMPARED TO THE PRIOR COMMAND PACKETS FROM THE PROGRAMMER. THIS RESULTED IN THE SOFTWARE INCORRECTLY CALCULATING SEVERAL VALUES THAT WERE RECEIVED TO DISPLAY. NOTE THAT THE ACTUAL DATA PROGRAMMED INTO THE GENERATOR WAS CORRECT AND THE ISSUE RESOLVED UPON RE-INTERROGATION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404754 ↗
• MalfunctionMar 7, 2019Computer Software Problem; Computer Software Problem

  IT WAS REVEALED DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, ON THE FIRST INTERROGATION AT A CLINIC VISIT, THE VNS BATTERY STATUS INDICATOR WAS FLAGGED AS END OF SERVICE, OR EOS. HOWEVER, AN ADDITIONAL INTERROGATION/DIAGNOSTICS PERFORMED AT THE SAME VISIT REVEALED THAT THE DEVICE WAS NOT AT EOS. REVIEW OF THE INTERNAL GENERATOR DATA REVEALED THAT THE VALUES THAT DID NOT CORRESPOND WITH THOSE VALUES EXPECTED FOR THE GENERATOR. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT SOME RESPONSE PACKETS OF DATA RECEIVED FROM THE GENERATOR VIA THE WAND WERE DUPLICATED AND/OR RECEIVED OUT OF SEQUENCE COMPARED TO THE PRIOR COMMAND PACKETS FROM THE PROGRAMMER. THIS RESULTED IN THE SOFTWARE INCORRECTLY CALCULATING SEVERAL VALUES THAT WERE RECEIVED TO DISPLAY. IT WAS DETERMINED THAT THIS WAS A ONE-TIME UI-BASED ERROR AND THE VNS GENERATOR WAS NEVER ACTUALLY AT EOS OR DISABLED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401904 ↗
• MalfunctionFeb 25, 2019Computer Software Problem; Computer Software Problem

  DIAGNOSTICS WERE OKAY AT THE PATIENT'S FOLLOW-UP APPOINTMENT. NO FURTHER RELEVANT INFORMATION RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 8367848 ↗
• MalfunctionJan 11, 2019Computer Software Problem; Computer Software Problem

  GUIDED PROGRAMMING IS AN OPTION FOR A MODEL 106 DEVICE. IT WAS DETERMINED THAT THE GUIDED PROGRAMMING FEATURE OF THE M3000 SOFTWARE WOULD NATURALLY PROMPT A M106 GENERATOR PROGRAMMED TO THE PATIENT'S INTENDED SETTINGS TO BE PROGRAMMED TO THE SETTINGS THAT THE PHYSICIAN REPORTED AS UNINTENDED. THE PHYSICIAN WOULD HAVE TO DECLINE THE SETTINGS CHANGE TO MANUALLY PROGRAM TO DESIRED SETTINGS. IN THIS CASE, THE PHYSICIAN ACCEPTED THE PROMPT WHICH LEAD TO THE SETTINGS CHANGE. NO DEVICE FAILURE IS EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242411 ↗
• MalfunctionDec 20, 2018Computer Software Problem; Energy Output Problem; Computer Software Problem; Energy Output Problem

  THROUGH REVIEW OF THE INTERNAL DATA OF THE TABLET, THE REPORT OF THE INVALID PARAMETERS WARNING MESSAGE ON 1.0.2.4 SOFTWARE. THROUGH A REVIEW OF THE GENERATOR'S OFFICE VISIT DATA, IT WAS FOUND THAT THE PATIENT'S GENERATOR HAD LAST BEEN PROGRAMMED APPROXIMATELY A MONTH PRIOR TO THE INVALID PARAMETERS MESSAGE BY A TABLET WITH UNKNOWN SOFTWARE VERSION. IF THE PATIENT WAS PROGRAMMED BY A 1.0.1.7 SOFTWARE VERSION DURING THE VISIT PRIOR TO THE VISIT WHERE THE INVALID PARAMETERS MESSAGE WAS SEEN, IT MAY HAVE TRIGGERED THE INVALID PARAMETERS MESSAGE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8185155 ↗
• MalfunctionOct 28, 2018Computer Software Problem; Computer Software Problem

  PHYSICIAN REPORTED THAT THE PATIENT'S DEVICE SETTINGS HAD CHANGED WITHOUT INTENTIONAL PROGRAMMING BY THE PHYSICIAN. THE PHYSICIAN ALTERED THE PATIENT'S DUTY CYCLE UP TOWARDS RAPID CYCLING, AND DID NOT CHANGE ANY OUTPUT CURRENT. HOWEVER, WHEN DEVICE WAS CHECKED AGAIN, THE OUTPUT CURRENT CHANGED AS WELL WITHOUT PHYSICIAN INTENDING THIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011478 ↗
• MalfunctionOct 28, 2018Computer Software Problem; Computer Software Problem

  PHYSICIAN REPORTED THAT THE PATIENT'S DEVICE SETTINGS HAD CHANGED WITHOUT INTENTIONAL PROGRAMMING BY THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011473 ↗
• MalfunctionOct 26, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT AT A DOSING APPOINTMENT FOR A PATIENT WITH A M102, THE DUTY CYCLE WAS FOUND TO BE AT 1% UPON ADVANCED INTERROGATION WITH M3000 V1.0 SOFTWARE. THE SESSION REPORT SHOWED THAT THE INITIAL AND FINAL INTERROGATION SETTINGS WERE AS EXPECTED. THE PATIENT'S SETTINGS WERE CORRECTED DURING THE SAME VISIT. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8010781 ↗
• MalfunctionOct 2, 2018Computer Software Problem; Computer Software Problem

  IT WAS DETERMINED THROUGH A REVIEW OF THE TABLET'S LOG FILES THAT THE CAUSE OF THE CHANGE IN SETTINGS WAS BE DUE THE FAULTED/INTERRUPTED DIAGNOSTICS TEST. THE REASON THAT THE SETTINGS INDICATIVE OF A FAULTED DIAGNOSTICS TEST DID NOT APPEAR IMMEDIATELY AFTER THE FAULTED TEST IN THE MANUFACTURER'S PROGRAMMING DATABASE (AND INSTEAD WAS LISTED AFTER A PROGRAMMING AND INTERROGATION EVENT) WAS DUE TO THE WAY DUE TO THE WAY THE MODEL 3000 TABLET DOCUMENTED EVENTS TO THE CSV FILE USED TO MAKE THE DATABASE. PER THE LOG FILES, THE PROGRAMMING EVENT JUST AFTER THE DIAGNOSTICS TESTS WAS ONLY CHANGING THE PATIENT'S IMPLANT DATE/ID. THE CSV FILE FOR A PROGRAMMING EVENT WILL ONLY UPDATE CHANGED PARAMETERS, WHERE ALL OTHERS WILL BE PULLED FROM MOST RECENT SUCCESSFUL INTERROGATION. AS SUCH, THE PROGRAMMING DATABASE SHOWS THE PRIOR SETTINGS BEFORE THE FAULTED TEST. DIRECTLY AFTER THIS PROGRAMMING EVENT, THE INTERROGATION EVENT INDICATED THAT THE SETTINGS WERE OK BECAUSE COMMUNICATION FAILED DURING THE EVENT. WHEN THE INTERROGATION FAILED, THE TABLET STILL RECORDED AN INTERROGATION ATTEMPT, BUT AUTO-PULLED DATA FROM THE MOST RECENT SUCCESSFUL INTERROGATION. THE SECOND INTERROGATION DID COMPLETE SUCCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927581 ↗
• MalfunctionFeb 16, 2018Mechanical Problem; Low impedance; Communication or Transmission Problem; Mechanical Problem; Low impedance; Communication or Transmission Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS EXPERIENCING COMMUNICATION ISSUES WHEN INTERROGATING A PATIENT'S GENERATOR. THE ERROR CODE DISPLAYED WAS "ERROR CODE 254 - APPLY CHANGES INTERRUPTED". FROM REVIEW OF THE PROGRAMMING DATA, IT WAS NOTED THAT THE DEVICE WAS IN A MAGNET INHIBIT STATE ON THE DAY OF THIS OFFICE VISIT. THE MAGNET INHIBIT STATE TRIGGERS WHEN A MAGNET IS PLACED OVER THE GENERATOR TO INHIBIT VNS STIMULATION PER USER DISCRETION. IN RESPONSE TO ATTEMPTING TO PROGRAM THE GENERATOR IN THIS STATE, THE PROGRAMMER INTERPRETED THE RESPONSE WITH THE "ERROR CODE 254" MESSAGE, WHICH IS A GENERIC MESSAGE FOR WHEN A PROGRAMMING EVENT MAY NOT HAVE BEEN SUCCESSFUL. THIS MESSAGE DOES NOT CONTAIN SPECIFIC CONTEXT TO THE ISSUE, BUT IMPLIES THAT RE-PERFORMING THE PROGRAMMING OPERATION MIGHT LEAD TO SUCCESS, ALTHOUGH IN THIS CASE, PROGRAMMING COULD NOT OCCUR AS LONG AS A MAGNET WAS PRESENT OVER THE DEVICE. IT WAS NOTED THAT THIS "MAGNET INHIBIT" CONDITION WAS NOT SEEN IN ANY OF THE PATIENT'S PREVIOUS SESSIONS OR WITH ANY OTHER SIMILAR DEVICES SEEN AT OTHER OFFICE VISITS. FOLLOW UP WITH THE PHYSICIAN INDICATED THAT A MAGNET WAS NOT CLOSE TO THE GENERATOR AT THE TIME OF PROGRAMMING. IT WAS NOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278519 ↗

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-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-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-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-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• 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.