VNS Therapy® Demipulse® Model 103 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 371 adverse event reports that list this exact device (DI 05425025750030), received between Oct 18, 2017 and Sep 21, 2026 — classified as 24 deaths, 218 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (23 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 371 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50847629 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient's caregiver that after their battery replacement, complications had occurred. The patient returned in for evaluation of the healing wound and everything was tightly closed. It was stated that about a week later, the patient experienced swelling and inflammation that looked like a big blister. The physician stated that they had used a thread instead for absorbable suture. It was stated that the medical team decided intervention would be needed as they stated it might be the thread that is not working. Surgical intervention was completed and the sutures were changed out for traditional sutures. The sutures were removed with minor bleeding, but overall adequate. About a month after the stiches were removed, the incision site showed signs of complication again such as redness, swelling, and pt. fever. It was noted that no infection was identified via cultures, however the patient's PCR had risen, and now the wound is mildly hyperemic. The patient was prescribed an antibiotic due to this PCR increase and hyperemia.Later, information was received indication that the plan to resolve this issue was to irrigate the surgical site with vancomycin.No additional k

  Patient problems: Anaphylactoid / Anaphylaxis; Fever; Hyperemia; Swelling/ Edema

  MAUDE report 50842621 ↗
• MalfunctionJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S SCHEDULED GENERATOR REPLACEMENT HAD TO BE CANCELLED DUE TO THE PATIENT HAVING MULTIPLE SEIZURES AND BEING UNSAFE TO TRANSPORT. THE PATIENT'S GENERATOR REPLACEMENT WAS RESCHEDULED. NO OTHER RELEVANT INFORMATION IS AVAILABLE TO DATE.

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

  MAUDE report 25657758 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCING A MINOR INFECTION AT THE VNS SITE. IT IS BELIEVED TO BE CAUSED BY AN INFECTION AT THE FOOT AND SPREAD TO THE VNS SITE. MEDICATION WAS PROVIDED TO THE PATIENT FOR THE INFECTION. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO BE RELATED TO THE FUNCTIONALITY OF THE DEVICE. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Skin Infection

  MAUDE report 24203608 ↗
• MalfunctionJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE AFTER DEVICE WAS ACTIVATED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 24132243 ↗
• MalfunctionJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ABNORMAL VOLUME OF SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 24117612 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE PATIENT THAT AFTER VNS IMPLANT THEY DEVELOPED ASTHMA. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Asthma

  MAUDE report 24099016 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S INCISION OPENED AFTER IMPLANT AND REQUIRED FOLLOW-UP FOR THE WOUND TO HEAL. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WAS STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Wound Dehiscence

  MAUDE report 24081041 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SINCE THE VNS, PATIENT FEELS LIKE SHE IS "HOLDING BREATH" AT NIGHT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Apnea

  MAUDE report 24070325 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  THE CAREGIVER REPORTED THAT THE PATIENT FEELS SAD AFTER SEIZURES, AS SHE EXPECTED NO SEIZURES FOLLOWING VNS IMPLANTATION. DESPITE MULTIPLE ADJUSTMENTS, SEIZURE FREQUENCY HAS IMPROVED FROM EVERY 1.5 DAYS TO EVERY 8 DAYS, BUT THE PATIENT REMAINS STRESSED AND IN LOW MOOD. ESCITALOPRAM WAS PRESCRIBED (DOSAGE UNKNOWN), WHICH IMPROVED MOOD AND SLEEP, THOUGH SADNESS PERSISTS AFTER SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 24061090 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT WAS HOSPITALIZED DUE TO INFECTION. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 24056122 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION FOLLOWING INITIAL IMPLANT SURGERY. PATIENT WAS HOSPITALIZED AND REQUIRED ADDITIONAL VISITS FOR DRAINAGE/REPOSITIONING OF STITCHES. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24038857 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SLEEP APNEA. IT WAS NOTED THAT THAT AS THE BATTERY FOR THE VNS BEGAN DEPLETING, THE APENA BEGAN TO IMPROVE SLIGHTLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 23976831 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTOPERATIVE PERIOD, THE PRESENCE OF INFECTION IN THE ELECTRODE REGION WAS OBSERVED, THE PATIENT USED ANTIBIOTICS, AFTER THE USE OF THE MEDICATIONS, THE INFECTION REGRESSED. PRODUCT RETURN AND DEVICE EVALUATION IS NOT NECESSARY AS THE REPORTED EVENT IS NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 23938508 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE SIZE OF THE IMPLANTED DEVICE, THE PATIENT OPENED THE INCISION LEADING TO INFECTION. THE DEVICE WAS REMOVED AND REPLACED. PRODUCT RETURN AND DEVICE EVALUATION IS NOT NECESSARY AS THE REPORTED EVENT IS NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Skin Infection; Wound Dehiscence

  MAUDE report 23938027 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN SEIZURE PATTERN AND NEW SEIZURE TYPES FOLLOWING VNS IMPLANTATION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23937281 ↗
• MalfunctionDec 23, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S BATTERY LIFE IS NOW AT IFI (INTENSFIED FOLLOWUP INDICATOR) =YES AND THEIR SETTINGS WERE PROVIDED AS 2MA/21SEC/3MIN. THE PATIENT'S DEVICE WAS JUST IMPLANTED ON (B)(6) 2024 AND IN (B)(6) 2025 THEIR BATTERY WAS AT 75-100%. INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. THE DEVICE HISTORY RECORDS FOR THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED ALL SPECIFICATIONS, INCLUDING QUALITY CONTROL INSPECTION, AND SHOWED NO NON-CONFORMITIES, PRIOR TO ITS RELEASE INTO THE FIELD FOR DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879274 ↗
• MalfunctionDec 16, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING PATIENT FOLLOW-UP, ERROR CODE 1 (DEVICE DISABLED ERROR) WAS SEEN. AFTERWARDS, WHEN THE PHYSICIAN CLICKED ¿ENABLED THERAPY¿ THE GENERATOR BECAME ACTIVE AND FROM THE RE-INTERROGATIONS NO WARNING APPEARED. TABLET DATA WAS LATER PROVIDED FOR REVIEW. 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 23819223 ↗
• MalfunctionDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE VNS DID NOT WORK FOR THEM AND THEIR SEIZURES GOT WORSE. THEY WOULD LIKE TO HAVE THE DEVICE REMOVED. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23790445 ↗
• MalfunctionDec 5, 2025Premature Discharge of Battery; Failure to Interrogate; Electrostatic Discharge; Premature Discharge of Battery; Failure to Interrogate; Electrostatic Discharge

  DURING A REVIEW FOR AN FDA REQUEST, IT WAS DISCOVERED THAT A CORRECTION REPORT IS NEEDED FOR A REPORT PREVIOUS SUBMITTED UNDER MANUFACTURING NUMBER 1644487-2011-00585. FOLLOW UP #3 (SUBMITTED 08/10/2011), FOLLOW UP #4 (SUBMITTED 08/19/2011) AND FOLLOW UP #5 (10/26/2011) WERE SUBMITTED UNDER THE INCORRECT MANUFACTURING REPORT NUMBER OF 1644487-2011-01531. THE MANUFACTURING REPORT NUMBER FOR FOLLOW UP #3, FOLLOW UP #4 AND FOLLOW UP #5 SHOULD HAVE BEEN MANUFACTURING REPORT NUMBER 1644487-2011-00585. FOLLOW UP #3 WOULD BE THE NEXT FOLLOW UP REPORT UNDER THE CORRECT MANUFACTURING NUMBER, HOWEVER IT WAS UNABLE TO BE SUBMITTED UNDER THE CORRECT MANUFACTURING REPORT NUMBER DUE TO ERRORS RECEIVED. DUE TO THE AGE OF THE PREVIOUS REPORTS, IT WAS RECOMMENDED BY THE CDRH HELP DESK TO CATEGORIZE THIS CORRECTION REPORT SUBMISSION AS AN INITIAL REPORT TO AVOID THE ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735347 ↗
• DeathDec 4, 2025Adverse 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 SUDEP AND THE PATIENT'S DEATH IS NOT RELATED TO VNS. THE DEVICE WAS NOT EXPLANTED PRIOR TO BURIAL; THEREFORE, IT IS UNAVAILABLE FOR RETURN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23722218 ↗
• InjuryNov 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATES HER VNS HAS RECENTLY CAUSED HER MORE VOICE HOARSENESS AND SHE HAS BEEN EXPERIENCING PAINFUL STIMULATION. THE PATIENT FURTHER STATES HER CHEST IS ALSO SORE OVER HER VNS SITE AND SHE CANNOT CARRY HER PURSE ON THAT SIDE ANYMORE. THE PATIENT HAS BEEN REFERRED TO THE SURGEON FOR REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort; Implant Pain; Voice alteration

  MAUDE report 23677306 ↗
• DeathNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LATER, THE PHYSICIAN STATED THAT THEY WERE "JUST INFORMED THAT THERE WAS SOME PAPERWORK FAXED TO THE OFFICE REGARDING A PATIENT WHO DIED A NUMBER OF YEARS AGO, UNRELATED TO HIS IMPLANT." BASED ON THIS RESPONSE. THE DEATH WAS COMMUNICATED TO NOT BE RELATED TO VNS. OF NOTE, THE PHYSICIAN HAD NOT FORMALLY COMPETED THE MANUFACTURER'S FOLLOW-UP WORKSHEET, HOWEVER BASED ON RESPONSE- THIS PROVIDES ENOUGH CONTEXT TO JUSTIFY THAT THE VNS WAS NOT THOUGHT TO BE THE CAUSE OF DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596347 ↗
• MalfunctionOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASE IN DEPRESSION. THE PATIENT SUSPECTS THAT IT'S DUE TO LOW BATTERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Depression

  MAUDE report 23404895 ↗
• MalfunctionJul 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD DEPLETED MUCH FASTER THAN THEY HAD ANTICIPATED. IN ADDITION TO THIS, THE PATIENT REPORTS THAT THEY ARE UNABLE TO PERCEIVE STIM DESPITE HAVING BATTERY LIFE REMAINING. THE PATIENT BELIEVES THAT THE DEVICE IS OPERATING OUT OF IT'S SPECIFICATIONS, HOWEVER THE IMPEDANCE PROVIDED INDICATES THAT THE DEVICE IS OPERATING WITHIN NORMAL LIMITS AS SPECIFIED BY THE MANUFACTURER'S LABELING (SEE SECTION B6.). NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Depression; No Clinical Signs, Symptoms or Conditions; Suicidal Ideation

  MAUDE report 22507491 ↗

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