VNS Therapy® Demipulse Duo® Model 104 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 05425025750047), received between Oct 31, 2017 and Sep 15, 2026 — classified as 20 deaths, 147 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Premature End-of-Life Indicator” (28 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 266 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient was admitted to the hospital due to dizzy spells. It was reported that it was unknown if the patient's dizzy spells were related to their VNS. The patient reported they had not seen a neurologist for many years. Programming history records for the patient's device were reviewed. The only recorded diagnostics for the patient are within normal limits. Device history records for the patient's generator were reviewed. The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information is available to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dizziness

  MAUDE report 50774136 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Convulsion, Clonic

  MAUDE report 25241221 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  LATER, AN UPDATE WAS RECEIVED INDICATING THAT EXTRUSION OF THE GENERATOR WAS SEEN RATHER THAN PROTRUSION. THIS EXTRUSION WAS PRECEDED BY "STICKY" DRAINAGE. THE MOTHER STATED THAT THE STIMULATOR HAS PROGRESSIVELY EMERGED MORE AND MORE OVER THE COURSE OF SEVERAL DAYS. THE GENERATOR WAS EXPLANTED AS A RESULT. THE LEAD REMAINS IMPLANTED. DURING THE EXPLANT OF THE GENERATOR, NO INCISION WAS NECESSARY SINCE THE GENERATOR WAS HANGING OUT OF THE WOUND THE GENERATOR. CULTURES WERE OBTAINED AND THE WOUND WAS THEN COPIOUSLY IRRIGATED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR AND LEAD. THE GENERATOR AND LEAD PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE GENERATOR AND LEAD WERE HP STERILIZED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Fluid Discharge; Peripheral Edema; Unspecified Tissue Injury

  MAUDE report 25060981 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE CAUSE OF THE INCREASED SEIZURES AND FALL ARE RELATED TO BOTH VNS STIMULATION AND EXTERNAL FACTORS. THE INTERVENTION TAKEN FOR THE EVENT WAS MEDICATION CHANGES AND DECREASING THE VNS STIMULATION.

  Patient problems: Ambulation or Postural Difficulties; Convulsion, Clonic

  MAUDE report 24999492 ↗
• DeathApr 23, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. IT WAS NOTED BY THE PROVIDER THAT THE CAUSE OF DEATH WAS UNKNOWN, BUT IT WAS NOT RELATED TO VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973322 ↗
• MalfunctionJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PRODUCT ANALYSIS TESTING ON THE GENERATOR WAS COMPLETED. NO ANOMALIES WERE DETECTED DURING TESTING. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 24170985 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24055606 ↗
• MalfunctionDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT'S DEVICE WAS NOTED TO BE NEARING END OF LIFE. THE PATIENT HAS BEEN REFERRED FOR A GENERATOR REPLACEMENT. THERE WAS NO INDICATION REFERRAL WAS FOR THE SEIZURES. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23936520 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SEIZURES HAS INCREASED OVER THE PAST COUPLE MONTHS LEADING TO HOSPITALIZATION. THE PATIENT WAS REFERRED TO NEUROSURGERY. RECENTLY IN JUNE 2025, IT WAS NOTED THAT THE PATIENT'S BATTERY HAS SINCE DEPLETED. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22608186 ↗
• DeathJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOR AN UNKNOWN REASON. REVIEW OF THE PATIENT'S OBITUARY REVEALED THE PATIENT PASSED AWAY ON (B)(6) 2025. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204138 ↗
• MalfunctionJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN AT THE EMERGENCY ROOM DUE TO SEIZURE ACTIVITIES. IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING INCREASE OR WORSEN SEIZURE ACTIVITIES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22178510 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY AND NO FURTHER DETAILS WERE PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719987 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT ANALYSIS WAS APPROVED FOR THE GENERATOR. AN INTERROGATION AND A SYSTEM DIAGNOSTIC TEST WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

  Patient problems: Discomfort

  MAUDE report 21699127 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 21697651 ↗
• MalfunctionJan 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT THE PATIENT WAS ALSO EXPERIENCING INCREASED DEPRESSION. THE PATIENT WAS PROVIDED ADDITIONAL MEDICATION IN RESPONSE TO THE INCREASED DEPRESSION AND WAS REFERRED FOR A BATTERY REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A FULL SYSTEM REVISION. IT WAS DETERMINED THAT THE GENERATOR HAD MIGRATED FOLLOWING THE PATIENT HAVING BREAST IMPLANT PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE MIGRATION WAS DUE TO THE BREAST IMPLANT PROCEDURE. UPON INTERROGATING THE DEVICE, HIGH IMPEDANCE AND LOW OUTPUT CURRENT WERE SEEN, THEREFORE A FULL SYSTEM REVISION WAS PERFORMED. THE EXPLANTED DEVICES WERE TAKEN TO PATHOLOGY AND HAVE NOT BEEN RETURNED TO LIVANOVA TO DATE. PER THE PHYSICIAN, THE PATIENT'S INCREASED DEPRESSION WAS CAUSED BY THE DEVICE NOT FUNCTIONING PROPERLY (HIGH IMPEDANCE). THE PATIENT'S DEPRESSION WAS NOTED TO BE ABOVE PRE-VNS BASELINE LEVELS THE REPORTED HIGH IMPEDANCE AND INCREASED DEPRESSION WILL BE CAPTURED IN REPORT 1644487-2025-00127. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124109 ↗
• DeathJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUSPECTED DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS. THE ANALYSIS OF THE DEVICE HAS NOT BEEN COMPLETED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112368 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WILL BE HAVING HER VNS EXPLANTED. PER THE MEDICAL ASSISTANT AT THE PHYSICIAN'S OFFICE, THE PATIENT HAS NOT BEEN USING HER DEVICE AND WHEN SHE DID, IT WAS CAUSING HER DISCOMFORT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S DEVICE WAS DISABLED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: Discomfort

  MAUDE report 20667191 ↗
• MalfunctionOct 4, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT AN ERROR CODE 128 (COMMUNICATION TIMEOUT) WAS OBSERVED WHILE TRYING TO INTERROGATE THE PATIENT'S GENERATOR. TROUBLESHOOTING WAS DONE WHICH INCLUDED REBOOTING THE WAND, REPLACING WAND BATTERIES, USING A WIRED CONNECTION BETWEEN THE WAND AND TABLET, AND INTERROGATING WITH ANOTHER PROGRAMMER. THE PHYSICIAN BELIEVED FAILURE TO INTERROGATE WAS DUE TO A LOW BATTERY AND THE PATIENT WAS REFERRED FOR A GENERATOR REPLACEMENT. UPDATE WAS RECEIVED THAT THE PATIENT HAD THEIR GENERATOR REPLACED. DURING THE SURGERY THE GENERATOR WAS STILL UNABLE TO BE INTERROGATED, ERROR CODE 128 KEPT SHOWING UP ON THE PROGRAMMER. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. THE SUSPECT GENERATOR HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371991 ↗
• DeathSep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO UNKNOWN REASON. THE REPORTING PHYSICIAN WAS UNABLE TO PROVIDE MORE INFORMATION REGARDING THE EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169818 ↗
• MalfunctionAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS EXPERIENCED AN INCREASE IN DEPRESSION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Depression

  MAUDE report 19907451 ↗
• MalfunctionJul 26, 2024Premature Discharge of Battery; Premature Discharge of Battery

  PRODUCT ANALYSIS FOR THE GENERATOR WAS COMPLETED. NO CAUSES FOR MIGRATION AND PAIN WERE IDENTIFIED. THE SURGEON USER ERROR WAS CONFIRMED AS THE DEVICE WAS CONFIRMED TO BE LIKELY IN THE PRESENCE OF ELECTRO CAUTERY. NO CORRECTIVE ACTION IS NEEDED AS THERE IS NO NEW HARM OR RISK ESTABLISHED FOR THE PATIENT OR USER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19838258 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S GENERATOR MOVED FROM THEIR POCKET AND CREATED A LARGE BRUISE WITH A LOT OF SWELLING. PATIENT SAW THEIR SURGEON AND WAS SCHEDULED FOR REPLACEMENT. SINCE THEN, THE SWELLING HAS GONE DOWN BUT THE GENERATOR IS NOW PROTRUDING FROM SKIN AND THE INCISION SITE IS LEAKING FLUID. THE PATIENT'S PHYSICIAN LATER REPORTED THAT THE CAUSE OF THE GENERATOR MIGRATION IS UNKNOWN BUT COULD BE FROM POSSIBLE INCREASE IN BREAST DEVELOPMENT AND PRESSURE FROM THEIR UNDERGARMENTS. IT WAS CONFIRMED A NON-ABSORBABLE SUTURE WAS USED TO SECURE THE GENERATOR DURING ITS IMPLANTATION. THE SWELLING IS RELATED TO THE DEVICE MIGRATION. THE PATIENT'S MOTHER LATER REPORTED THAT THE DEVICE WAS EXPLANTED. WHEN THE PATIENT GOT TO SURGERY, THE DEVICE WAS "HALF OUT." NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Ecchymosis; Pocket Erosion

  MAUDE report 19783627 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS HOSPITALIZED DUE TO INCREASED SEIZURES. AN URGENT BATTERY REPLACEMENT IS REQUESTED AS THE DEVICE IS SUSPECTED TO BE DEPLETED. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 19604643 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT A PROPHYLACTIC BATTERY REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 19173551 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GENERATOR WAS EXPLANTED DUE TO INFECTION. IT WAS REPORTED THAT THE INFECTION THE PATIENT INCURRED, RESULTED IN DYSPHAGIA FOR THE PATIENT. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Dysphagia/ Odynophagia; Hematoma; Pocket Erosion; Post Operative Wound Infection

  MAUDE report 19000987 ↗

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-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-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.