VNS Therapy® Programmer, Model 3000 v1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05425025750399), received between Nov 17, 2017 and May 30, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2019Computer Software Problem; Computer Software Problem

  REVIEW OF THE EXPORT DATA WITH QE REVEALED IT WAS LIKELY THAT THE MEDICAL PROFESSIONAL DID NOT SWIPE THE MAGNET UPON PERFORMING MAGNET MODE DIAGNOSTICS. IT WAS DETERMINED BASED OFF OF THE REVIEW THAT THE FALSE LOW OUTPUT CURRENT LIKELY APPEARED BECAUSE THE MAGNET SETTINGS WERE CHANGED PRIOR TO PERFORMING THE TESTS, SUCH THAT THE LAST DELIVERED MAGNET PULSE STORED IN THE IPG DID NOT MATCH THE NEW VALUE AS NO MAGNET SWIPE HAD OCCURRED YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654054 ↗
• MalfunctionJan 8, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE DOCTOR INTERROGATED THIS PATIENT'S DEVICE AND THE IMPEDANCE CAME BACK NORMAL HOWEVER THE CURRENT DELIVERED CAME BACK LOW. WHEN THE PATIENT'S DEVICE WAS INTERROGATED LATER, THE IMPEDANCE CAME BACK AS NORMAL, AND THE OUTPUT CURRENT WAS ALSO STATED TO BE WITHIN NORMAL LIMITS. INTERNAL PROGRAMMING HISTORY WAS REVIEWED WHICH REVEALED THAT THE PATIENT¿S OUTPUT CURRENT SETTINGS (NORMAL, MAGNET AND AUTOSTIM) WERE INCREASED AT THE OFFICE VISIT. AFTER THE SETTINGS WERE INCREASED A SYSTEM DIAGNOSTIC, AUTOSTIM DIAGNOSTIC AND MAGNET MODE DIAGNOSTIC WERE PERFORMED IN SUCCESSION. THE LOW OUTPUT CURRENT WARNING WAS SEEN AFTER MAGNET MODE DIAGNOSTICS WERE PERFORMED, WHERE A MAGNET MUST BE SWIPED FOR THE TEST TO PERFORM AS INTENDED. IT WAS CONFIRMED THROUGH A SYSTEM DIAGNOSTIC TEST THAT THE APPROPRIATE OUTPUT CURRENT IS BEING DELIVERED. THIS EVENT HAS BEEN DETERMINED TO BE DUE TO SOFTWARE ERROR IN THE M3000 PROGRAMMER THAT CAUSES THE SUMMARY SCREEN TO BE UPDATED EVEN IF AN INCOMPLETE MAGNET MODE DIAGNOSTIC TEST IS PERFORMED (NO MAGNET SWIPE PRIOR TO PERFORMING MAGNET MODE DIAGNOSTICS). NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8226520 ↗
• MalfunctionJun 29, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE NEUROLOGIST INTERROGATED A PATIENT'S DEVICE AND THE PATIENT'S OUTPUT CURRENTS WERE DISABLED FOR NORMAL MODE, MAGNET MODE AND AUTOSTIMULATION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650983 ↗
• MalfunctionMar 14, 2018Computer Software Problem; Improper Device Output; Computer Software Problem; Improper Device Output

  IT WAS REPORTED THAT THIS PATIENT WAS VISITING THE DOCTOR¿S OFFICE AND THEIR AUTOSTIM WAS TURNED OFF. THE MEDICAL ASSISTANT HAD SEEN AN ERROR MESSAGE BUT COULD NOT REMEMBER WHAT IT WAS. THE PATIENT WAS SAID TO HAVE BEEN PROGRAMMED WITH THE M3000 PROGRAMMING SOFTWARE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339779 ↗
• MalfunctionJan 19, 2018Incorrect Software Programming Calculations; Incorrect Software Programming Calculations

  UPON INTERROGATION OF THE GENERATOR, IT WAS NOTICED THAT THE GENERATOR SETTINGS WERE RESET, WHICH WAS NOT EXPECTED. IT WAS DETERMINED THAT THE NEW PROGRAMMING SYSTEM WAS NOT USED AND THAT THE WARNING MESSAGE SEEN WAS A BURST WATCHDOG WARNING. DUE TO BURST WATCHDOG, THE SETTINGS UPON INTERROGATION WERE AT 0 MA ON (B)(6) 2017 INSTEAD OF THE PREVIOUSLY PROGRAMMED OUTPUT CURRENT OF 0.25 MA. THIS BURST WATCHDOG TIMEOUT EVENT IS BELIEVED TO BE DUE TO A SOFTWARE ERROR IN THE MODEL 3000 PROGRAMMER THAT CAUSES CERTAIN PARAMETERS TO BE INCORRECTLY CALCULATED IN M106 GENERATORS. THIS OCCURRED BECAUSE, WHILE THE PATIENT WAS SET TO A 0.25 MA NORMAL MODE OUTPUT CURRENT AND 0.5 MA MAGNET OUTPUT CURRENT, THE PATIENT'S FREQUENCY WAS CHANGED BY A MODEL 3000 PROGRAMMER WITHOUT A SUBSEQUENT PROGRAMMING STEP TO ADJUST MAGNET OR AUTOSTIMULATION OUTPUT CURRENT. THE PATIENT WAS PROGRAMMED BACK ON WITH A MODEL 250 TABLET. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7205954 ↗
• MalfunctionDec 22, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THAT WHEN THE PATIENT'S DEVICE WAS INTERROGATED A BURST WATCHDOG TIMEOUT WARNING WAS SEEN AND ALL OUTPUTS WERE SET TO ZERO. THE PATIENT'S DEVICE WAS PROGRAMED ON AFTER IMPLANT WITH A PROGRAMING TABLET INSTALLED WITH M3000 V1.0 SOFTWARE. AT A FOLLOW-UP APPOINTMENT, THE PATIENT WAS INTERROGATED AND A BURST WATCHDOG TIMEOUT WARNING WAS SEEN AND ALL OUTPUTS WERE SET TO ZERO. THE DEVICE WAS PROGRAMED BACK TO THE PREVIOUS, NORMAL SETTINGS. THE DATA FROM THE TABLET WITH M3000 V1.0 SOFTWARE HAS BEEN RECEIVED FOR ANALYSIS. ANALYSIS OF THE DATA HAS BEEN COMPLETED AND CONFIRMS THE EVENT IS DUE TO A PROGRAMMING SOFTWARE ISSUE THAT WOULD LEAVE THE PATIENT'S DEVICE SUSCEPTIBLE TO A BURST WATCHDOG TIMEOUT. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7144294 ↗
• MalfunctionDec 20, 2017Energy Output To Patient Tissue Incorrect; Improper Device Output; Energy Output To Patient Tissue Incorrect; Improper Device Output

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION THAT OCCURRED WHEN THE MAGNET WAS SWIPED. THE PATIENT ONLY STARTED EXPERIENCING THIS PAIN SINCE THE MOST RECENT ADJUSTMENT, MADE WITH THE M3000 PROGRAMMER. THE PATIENT WAS TOLD TO STOP USING THE MAGNET, UNTIL THEIR SETTINGS COULD BE ADJUSTED BY THE DOCTOR. THE PATIENT WAS SEEN 3 WEEKS LATER TO REPROGRAM THEIR GENERATOR USING AN OLDER PROGRAMMING SYSTEM. THE MAGNET CURRENT WAS REDUCED TO HELP WITH TOLERABILITY. SYSTEM DIAGNOSTICS WERE RUN AND WERE WITHIN NORMAL LIMITS. THE PATIENT FELT MUCH BETTER ABOUT THE SETTINGS AFTER THIS APPOINTMENT. THESE EVENTS HAVE BEEN DETERMINED TO BE DUE TO SOFTWARE ERROR IN THE M3000 PROGRAMMER THAT CAUSES CERTAIN PARAMETERS TO BE INCORRECTLY CALCULATED IN M106 GENERATORS. THESE INCORRECT CALCULATIONS ALONG WITH A COMBINATION OF PROGRAMMED SETTINGS, MAGNET SWIPES, AND AUTOSTIMULATION MAY LEAD TO A PERIOD OF CONTINUOUS CURRENT RAMPING FOR PART OR ALL OF AN ENTIRE THERAPY BURST. DURING THIS RAMPING, THE CURRENT CAN EXCEED PROGRAMMED VALUES . THIS IS LIKELY THE CAUSE OF THE PATIENT'S REPORTED PAINFUL STIMULATION. TO RESOLVE THIS ISSUE, THE PATIENT'S SETTINGS WERE REPROGRAMMED TO AVOID TH

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 7133752 ↗
• MalfunctionDec 11, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  FURTHER INFORMATION WAS RECEIVED THAT THE DEVICE WAS FOUND DISABLED DUE TO BURST WATCHDOG TIMEOUT AT THE FIRST INTERROGATION AFTER IMPLANT. FURTHER, AN ERROR WAS PRESENT FOR THE NUMBER OF PULSES PER RAMP STEP FOR MAGNET AND AUTOSTIM CURRENTS. FOR MAGNET STIMULATION IN PARTICULAR, THIS WOULD HAVE CAUSED RAMP UP / DOWN TIMES TO EXTEND FAR ENOUGH THAT A BURST WATCHDOG TIMEOUT WOULD OCCUR ON A MAGNET STIMULATION. OUTPUT CURRENT WAS TURNED BACK ON WITH THE V11 TABLET, WHICH RESULTED IN CORRECTION OF THE PULSE COUNT CALCULATIONS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105057 ↗
• MalfunctionNov 17, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THAT THE PATIENT'S VNS GENERATOR WAS PROGRAMMED ON AFTER THE VNS IMPLANT SURGERY USING A NEW VNS PROGRAMMING TABLET WITH M3000, VERSION 1.0, SOFTWARE. HOWEVER, AT THE FOLLOW UP VISIT WITH THE PATIENT'S PHYSICIAN A FEW WEEKS LATER, INTERROGATION WITH A M250, VERSION 11, SOFTWARE TABLET REVEALED THAT THE SETTINGS HAD BEEN CHANGED. THE COMPANY REPRESENTATIVE INDICATED THAT THE HOSPITAL DID NOT HAVE A VNS PROGRAMMER, SO IT WAS UNLIKELY THAT THE VNS HAD BEEN REPROGRAMMED. REVIEW OF THE M3000 PROGRAMMING DATA INDICATES THE DEVICE WAS PROGRAMMED IN SUCH A WAY TO BE SUSCEPTIBLE TO BURST WATCHDOG TIMEOUTS FOLLOWING A MAGNET SWIPE. REVIEW OF THE PHYSICIAN'S TABLET DATA CONFIRMS THE BURST WATCHDOG TIMEOUT WAS FOUND AT THE FOLLOW-UP APPOINTMENT AND HAD A SINGLE COMPLETED MAGNET STIMULATION LOGGED. THIS IS LIKELY THE EVENT THAT RESULTED IN THE BURST WATCHDOG TIMEOUT. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7043182 ↗
• MalfunctionNov 17, 2017Energy Output To Patient Tissue Incorrect; Improper Device Output; Energy Output To Patient Tissue Incorrect; Improper Device Output

  IT WAS REPORTED THAT A PATIENT WHO WAS RECENTLY IMPLANTED WITH A M106 DEVICE HAS COMPLAINED OF PERCEIVING STIMULATION STRONGER THAN HE HAD BEFORE HE WAS PROGRAMMED WITH THE M3000 PROGRAMMING SYSTEM. IT WAS STATED THAT THE PATIENT WAS REPROGRAMMED BACK TO INTENDED SETTINGS WITH THE M250 V.11.0 SOFTWARE PROGRAMMING SYSTEM AND STATED THAT HE FELT FINE AGAIN AFTER THEY WERE ADJUSTED. DATA WAS REVIEWED FROM M3000 PROGRAMMER WHICH CONTAINED INTERROGATION AND PROGRAMMING EVENTS FOR THE M106 FROM (B)(6) 2017, AND FROM A V11 TABLET CONTAINING INTERROGATION AND PROGRAMMING EVENTS FOR M106 FROM (B)(6) 2017. OFFICE VISIT DATA STORED WITHIN THE GENERATOR'S MEMORY ALSO INDICATED THAT THE PATIENT WAS ALSO INTERROGATED/PROGRAMMED ON (B)(6) 2017 BUT NO CORRESPONDING EVENTS WERE FOUND WITHIN THE DATABASES OF THE TWO TABLETS REVIEWED. ON (B)(6) 2017, THE DEVICE HAD PROGRAMMING ADJUSTMENTS TO NORMAL, MAGNET, AND AUTOSTIM OUTPUT CURRENTS USING THE MODEL 3000 TABLET. BASED ON THE AVAILABLE DATA, IT APPEARS THAT THE NORMAL MODE AND MAGNET MODE CURRENTS WERE ADJUSTED AGAIN ON (B)(6) 2017 WITH A DIFFERENT V11 TABLET WHILE AUTOSTIM WAS LEFT THE SAME. HAVING AUTOSTIM OUTPUT CURRENT PROGRAMMED WITH A MODEL 30

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 7043147 ↗
• MalfunctionNov 17, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT'S GENERATOR WAS DISABLED DUE TO A BURST WATCHDOG TIMEOUT. THE PATIENT HAD PREVIOUSLY BEEN PROGRAMMED BY A TABLET WITH MODEL 3000 V1.0 SOFTWARE. THE PATIENT'S MAGNET MODE OUTPUT CURRENT WAS HIGHER THAN THE AUTOSTIMULATION MODE OUTPUT CURRENT. THIS BURST WATCHDOG TIMEOUT EVENT IS BELIEVED TO BE DUE TO A SOFTWARE ERROR IN THE MODEL 3000 PROGRAMMER THAT CAUSES CERTAIN PARAMETERS TO BE INCORRECTLY CALCULATED IN M106 GENERATORS. THIS OCCURRED BECAUSE, WHILE THE PATIENT WAS SET TO A 0.25 MA NORMAL MODE OUTPUT CURRENT AND 0.5 MA MAGNET OUTPUT CURRENT, THE PATIENT'S FREQUENCY WAS CHANGED BY A MODEL 3000 PROGRAMMER WITHOUT A SUBSEQUENT PROGRAMMING STEP TO ADJUST MAGNET OR AUTOSTIMULATION OUTPUT CURRENT. THE PATIENT WAS PROGRAMMED BACK ON WITH A MODEL 250 TABLET. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042735 ↗

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.