VNS Therapy® Symmetry™ Model 8103 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 05425025750504), received between Jun 16, 2020 and Sep 17, 2026 — classified as 8 deaths, 163 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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 223 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50808392 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient was experiencing low oxygen saturation. The event was assessed as possibly related to stimulation. No action was taken for the event.No other relevant information has been received to date.

  Patient problems: Hypoxia

  MAUDE report 50756213 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a patient that they were suicidal and in need of a new physician. The patient indicated they had been fired from their previous physicians clinic and had not been seen by a physician for a few months.No other relevant information is available to date.

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

  MAUDE report 50677204 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had experienced an adverse event of worsening of suicidal ideation. This event as assessed as possibly related to stimulation and not related to procedure or presence of device. The event did meet serious adverse event criteria and is still is considered an ongoing issue.Later, the study reconciliation report was reviewed. The Worsening of suicidal ideation was noted to have resulted in a hospitalization. This event is considered 'severe' and noted to be ongoing.No other relevant information has been received to date.

  Patient problems: Suicidal Ideation

  MAUDE report 50550093 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  The patient had their device disabled as she felt it put her into a deep depression. The patient is now wanting to have the device removed.No known surgical intervention has occurred to date.No other relevant information has been received to date.

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

  MAUDE report 50160901 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED LOSING WEIGHT AND THEIR GENERATOR POCKET BEING QUITE ROOMY. THE PATIENT WAS REFERRED FOR SURGERY. ADDITIONAL DETAILS RECEIVED NOTING THAT THE PATIENT SLIPPED AND FELL IN (B)(6) 2026 AND THE PATIENT EXPERIENCED GENERATOR SITE DISCOMFORT. THE DEVICE INTERROGATION SHOWED THE VNS WAS FUNCTIONING WITHIN EXPECTED PARAMETERS. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 25351130 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING WORSENING OF SUICIDAL IDEATION, AND SUICIDE ATTEMPT BY INTENTIONAL OVERDOSE ON. THESE EVENTS ARE CONSIDERED AS SERIOUS ADVERSE EVENTS. IT WAS NOTED THAT THESE EVENTS ARE POSSIBLY RELATED TO VNS STIMULATION. THE PATIENT HAS NOW RECOVERED FROM THESE EVENTS. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED DUE TO THESE EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 25259862 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AFTER A RECENT IMPLANT. THE PHYSICIAN REPORTED THAT THE PATIENT HAD NOT FOLLOWED POST-IMPLANT CARE INSTRUCTIONS. IT IS THE OPINION OF THE PHYSICIAN THAT THE EVENT IS NOT RELATED TO THE STERILITY OF THE DEVICE OR THE IMPLANT PROCEDURE, BUT RATHER DUE TO THE FAILURE OF THE PATIENT TO FOLLOW POST SURGERY INSTRUCTIONS. THE DEVICE REMAINS IMPLANTED AND THE PATIENT IS UNDERGOING TRITURATION. DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED AS NOT RELATED TO VNS THERAPY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 25137468 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  LATER, AN UPDATE WAS RECEIVED FROM THE STUDY'S RECONCILIATION TEAM, INDICATING THAT THE SLEEP APNEA WAS NOW DETERMINED TO BE NOT RELATED TO THE DEVICE OR IMPLANT PROCEDURE. THE SLEEP APNEA REMAINS POSSIBLY RELATED TO VNS STIMULATION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 24987719 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT WAS EXPERIENCING SLEEP APNEA POSSIBLY RELATED TO STIMULATION AND POSSIBLY RELATED TO THE DEVICE. THE SUBJECT HAS BEEN PLACED ON CPAP MACHINE AND IS NOT EXPERIENCING A SERIOUS DETERIORATION IN HEALTH. THE EVENT HAS NOT RESOLVED OR RECOVERED. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 24782094 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED SLEEP APNEA. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO STIMULATION/DEVICE; OUTCOME IS RECOVERED/RESOLVED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 24640262 ↗
• DeathMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD COMMITTED SUICIDE, ATTEMPTS TO THE PHYSICIAN FOR ADDITIONAL INFORMATION WERE MADE. NO NEW RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590627 ↗
• MalfunctionFeb 6, 2026Insufficient Device Problem Information

  THE PATIENT REPORTED THAT HER SETTINGS WERE INCORRECTLY SET AND THEIR DEVICE IS NOT WORKING PROPERLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278685 ↗
• MalfunctionJan 7, 2026Premature Discharge of Battery; Failure to Interrogate; Insufficient Device Problem Information

  PRODUCT ANALYSIS WAS COMPLETED ON THE SUSPECT PRODUCT. THE GENERATOR WOULD NOT COMMUNICATE SO AN INTERROGATION, A SYSTEM DIAGNOSTIC TEST, MEASURED OUTPUT VOLTAGE, VBATT CALCULATION, AND A COMPREHENSIVE, AUTOMATED ELECTRICAL EVALUATION (FET) COULD NOT BE PERFORMED. THE GENERATOR WAS OPENED AND THE BATTERY VOLTAGE WAS MEASURED, 0.828V WHICH CONFIRMED AN EOS CONDITION. A COMPREHENSIVE, AUTOMATED PCBA ELECTRICAL EVALUATION WAS PERFORMED. A BULGE IN THE GENERATOR INDICATED A SWOLLEN BATTERY. X-RAY IMAGES SHOWED LOOSE FOREIGN DEBRIS WITHIN THE CASE, WHICH IS SUSPECTED TO BE A PIECE OF EXCESS FEEDTHRU WIRE. THE EXCESS WIRE CAUSED THE GENERATOR TO HAVE A SHORT CIRCUIT, CAUSING A RAPID DISCHARGE OF BATTERY CURRENT. DURING MANUFACTURING, EXCESS FEEDTHRU WIRE IS CLIPPED OFF PRIOR TO SOLDERING THE BATTERY TO THE PCBA AND THE CLIPPINGS ARE DISCARDED. IN THIS CASE, THE CLIPPING LIKELY LANDED ON THE DEVICE FOLLOWING CLIPPING AND WAS NOT DISCARDED. NO COMMUNICATION WAS DUE TO EOS CONDITION OF THE BATTERY WHICH APPEARS TO BE CAUSED BY AN INTERNAL SHORT, HIGH CURRENT EVENT THAT DRAINED/DAMAGED THE BATTERY. THERE WAS NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996379 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  TACHYCARDIA WAS REPORTED FOR THE STUDY PATIENT. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO SIMULATION / DEVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Tachycardia

  MAUDE report 23984614 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE INITIAL REPORT OF SELF-HARM WAS NOTED TO HAVE OCCURRED PRIOR TO VNS IMPLANT THEREFORE IT WILL BE CONSIDERED AS NOT RELATED TO VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 23906894 ↗
• MalfunctionDec 26, 2025High impedance; Incomplete or Inadequate Connection; High impedance; Incomplete or Inadequate Connection

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT SURGERY AND ONCE THE LEAD PIN WAS REMOVED AND THEN REINSERTED, THE LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. THE GENERATOR WAS THEN TESTED WITH A TEST RESISTOR AND THE IMPEDANCE WAS WITHIN NORMAL LIMITS, 4000 OHMS RULING OUT A GENERATOR ISSUE. THE GENERATOR WAS THEN RECONNECTED TO THE LEAD AND THE IMPEDANCE REMAINED WITHIN NORMAL LIMITS. NO DEVICES WERE REPLACED SINCE THE HIGH IMPEDANCE RESOLVED BY REINSERTED AND SECURING THE LEAD PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896303 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENTS REPORTED WERE NOT RELATED TO VNS AND INTERVENTION WAS TAKEN FOR PATIENT COMFORT ONLY.

  Patient problems: Cough; Dizziness; Dysphagia/ Odynophagia; Syncope/Fainting; Voice alteration

  MAUDE report 23790437 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT WAS ALSO EXPERIENCING NECK WOUND INFLAMMATION. WHICH CAUSED LED TO PROLONGED HOSPITALIZATION. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT SERIOUS INJURY. THE START DATE OF THE EVENT WAS 9/3/2025. IT WAS OF MODERATE SEVERITY, CAUSAL RELATIONSHIP WITH THE IMPLANT/PROCEDURE AND NOT RELATED TO STIMULATION/DEVICE. ACTION WAS TAKEN IN TERMS OF ADDED MEDICATION, THE TREATMENT WAS WITHDRAWN, DIAGNOSTIC EXAMINATIONS AND TESTS, AND SURGICAL CONSULTATION. THE PATIENT RECOVERED FROM THIS EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 23723055 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VNS THE PATIENT EXPERIENCED ASYSTOLE AND WAS BROUGHT BACK AFTER A SEIZURE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Asystole; Coma

  MAUDE report 23662899 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFTER MONTHS OF HAVING THE DEVICE IMPLANTED, THE PATIENT BEGAN EXPERIENCING CHEST PAIN, FATIGUE, AND PERSISTENT TIREDNESS. IT WAS STATED THAT AFTER ATTEMPTING TO MANAGE ALL THE CLINICAL SYMPTOMS THE PATIENT WAS PRESENTING, THEY DECIDED TO REFER HIM TO THE NEUROSURGEON TO RELOCATE THE GENERATOR TO THE RIGHT PECTORAL AREA. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Extreme Exhaustion; Implant Pain

  MAUDE report 23624801 ↗
• MalfunctionNov 13, 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. THE EXPLANTED GENERATOR WAS DISCARDED.

  Patient problems: Convulsion, Clonic

  MAUDE report 23550339 ↗
• MalfunctionNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE WAS RECEIVED. THE EVENTS WERE PREVIOUSLY ASSESSED AS NOT RELATED TO THE VNS.

  Patient problems: Depression

  MAUDE report 23521863 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT PHYSICIANS DETERMINED THE PATIENT'S SYMPTOMS WERE NOT RELATED TO VNS. DURING THE PATIENT'S HOSPITALIZATION, MEDICATION WAS ADDED AND ADJUSTED. THE PATIENT LATER UNDERWENT EXPLANT. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23457809 ↗
• MalfunctionOct 29, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE GENERATOR'S BATTERY LIFE WAS PREVIOUSLY SEEN OK; HOWEVER, ON THE MOST RECENT INTERROGATION, THE BATTERY WAS NOW OBSERVED LOW. PROGRAMMING DATA WAS PROVIDED FOR REVIEW. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414474 ↗

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.