VNS Therapy® Pulse Model 102 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05425025750016), received between Nov 2, 2017 and Jul 17, 2026 — classified as 6 deaths, 57 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO INCREASED 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 25856535 ↗
• DeathFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AFTER AN IMPATIENT STAY WITH MULTIPLE INTUBATIONS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 24345638 ↗
• MalfunctionDec 30, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT, AND DURING PRE-OP CHECKS, THE VNS DEVICE SHOWED AS DISABLED AT 0 MA OUTPUT CURRENT. THE REP INITIALLY ASSUMED THIS WAS INTENTIONAL, BUT IN THE OPERATING ROOM, THE SURGEON CONFIRMED THEY HAD CHECKED THE BATTERY WEEKS EARLIER AND HAD NOT DISABLED THERAPY OR CHANGED SETTINGS. THE REPLACEMENT PROCEEDED NORMALLY, AND AFTERWARD, THE REP REVIEWED THE PHYSICIAN¿S TABLET AND CONFIRMED NO CHANGES HAD BEEN MADE IN PRIOR SESSIONS. BOTH THE REP AND SURGEON ARE UNSURE IF THE PATIENT HAD AN MRI OR OTHER PROCEDURES REQUIRING THERAPY TO BE DISABLED. DIAGNOSTICS WERE NORMAL, AND THE BATTERY STATUS WAS OK. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930877 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VNS NEVER WORKED FOR THE PATIENT AND THEY CONTINUED TO HAVE BREAKTHROUGH SEIZURES AND THEIR SEIZURES SPREAD. THE PATIENT LATER UNDERWENT EXPLANT. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23328087 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S APNEA LIKELY BEGAN WITH FIRST VNS IMPLANT IN (B)(6) 2012. PATIENT HAD FIRST POSITIVE SLEEP STUDY IN (B)(6) 2015. THE CAUSE OF THE SLEEP APNEA IS REPORTEDLY RELATED TO VNS STIMULATION. THE PATIENT LATER HAD A PROPHYLACTIC EXPLANT, AND THE DEVICE WAS RECEIVED AND UNDERWENT PRODUCT ANALYSIS.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 23098258 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR VNS REMOVED DUE TO PAINFUL STIMULATION. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 22126000 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SEEN IN CLINIC AND HAD THEIR DEVICE INTERROGATED. THE DEVICE WAS THEN DISABLED AND THE PATIENT WAS REFERRED FOR EXPLANT AS THE PATIENT WOULD LIKE TO HAVE THE DEVICE REMOVED. THE PATIENT IS WANTING TO HAVE THE DEVICE REMOVED DUE TO PAIN. THE PAIN IS AT THE GENERATOR SITE AND HAS BEEN ONGOING FOR ABOUT 1.5 YEARS AND IS GETTING WORSE. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT HAD THEIR GENERATOR AND LEAD EXPLANTED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Implant Pain

  MAUDE report 19586123 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 17413228 ↗
• MalfunctionMay 22, 2023Premature Discharge of Battery; Defective Component; Premature Discharge of Battery; Defective Component

  A GENERATOR WAS EXPLANTED AND RETURNED DUE TO BATTERY DEPLETION. GENERATOR PRODUCT ANALYSIS WAS APPROVED FOR THE RETURNED GENERATOR. THE GENERATOR WAS UNABLE TO BE INTERROGATED. A MEASURED BATTERY VOLTAGE CONFIRMED THE DEVICE AT END OF SERVICE (EOS = YES). DURING THE FUNCTIONAL ANALYSIS, A DECREASE IN THE SUPPLY CURRENT WAIT WAS OBSERVED. THE DECREASE WAS OBSERVED WHEN THE C6 CAPACITOR WAS ISOLATED FROM THE CIRCUIT. AFTER THE CAPACITOR WAS SUBSTITUTED WITH AN EXTERNAL CAPACITOR, THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE NO COMMUNICATION AND THE END-OF-SERVICE (EOS) CONDITION WAS IDENTIFIED TO BE A LEAKY CAPACITOR (C6). CAUSE FOR THE CAPACITORS (C6) INCREASE IN LEAKAGE COULD NOT BE DETERMINED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975299 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PATIENT'S DEVICE HAS BEEN DEAD FOR A FEW YEARS AND SHE WANTED TO HAVE IT REMOVED. AN UPDATE WAS RECEIVED THAT THE PATIENT WILL BE HAVING THEIR DEVICE EXPLANTED DUE TO BATTERY DEPLETION AND PAIN AT THE GENERATOR SITE. RESPONSE FROM THE PHYSICIAN NOTES THAT THE CAUSE OF THE PATIENT'S PAIN IS DUE TO THE PRESENCE OF THE DEVICE. IN ADDITION, PER THE PHYSICIAN, THE PLANNED EXPLANT IS TO PREVENT SERIOUS INJURY. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Implant Pain

  MAUDE report 16846667 ↗
• MalfunctionApr 25, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT THE PATIENTS DEVICE WAS UNABLE TO BE INTERROGATED DUE TO BATTERY DEPLETION. THE PATIENT ALSO EXPERIENCED AN INCREASE IN SEIZURES. CLINIC NOTES WERE LATER RECEIVED WITH THE LAST SETTINGS PROVIDED. IT WAS NOTED THAT THE BATTERY-LIFE REPORT WAS NOT AVAILABLE AND THAT THE DEVICE WAS NO LONGER WORKING. IT WAS CONCLUDED THAT THE PATIENTS INCREASE IN SEIZURES WERE RELATED TO THE LOSS OF VNS THERAPY. SIMILARLY, THE DEVICE WAS CONCLUDED TO BE DEPLETED. AN IMPLANT CARD WAS LATER RECEIVED REPORTING THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT AND THE REASON FOR REPLACEMENT WAS FOR PROPHYLACTIC REASONS. A SESSION REPORT FROM THE DAY OF SURGERY WAS ALSO PROVIDED SHOWING THE BATTERY WAS NOT DEPLETED AND OBSERVED AT OK STATUS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 16808915 ↗
• MalfunctionApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GENERATOR PRODUCT ANALYSIS WAS APPROVED FOR THE RETURNED GENERATOR. THE GENERATOR WAS EXPLANTED DUE TO BATTERY DEPLETION. THE GENERATOR WAS UNABLE TO BE INTERROGATED. THE GENERATOR WAS OPENED AND THE MEASURED BATTERY VOLTAGE CONFIRMED THE GENERATOR AT AN END OF SERVICE (EOS) CONDITION. OTHER THAN THE EVENT OF NO COMMUNICATION DUE TO EOS, THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

  Patient problems: Convulsion, Clonic

  MAUDE report 16743786 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO HAVE A LARGE LIPOMA REMOVED FROM THEIR LEFT CHEST AND AXILLA AND GENERATOR REPLACEMENT. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED AS NOT RELATED TO VNS THERAPY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Subcutaneous Nodule

  MAUDE report 16307367 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BEEN HAVING TROUBLE WITH HER DEVICE FOR THE PAST SIX MONTHS. PATIENT HAS HAD MUSCLE SPASMS FROM HER HEAD TO THE BOTTOM OF HER ABDOMEN, AND SHOCKING DOWN THE LEFT SIDE OF HER CHEST. PATIENT NOTES THAT EVER SINCE SHE HAS HAD THE DEVICE, IT HAS BEEN PAINFUL YET TOLERABLE ONCE HER SETTINGS WERE MANAGED. OVER THE PAST 6 MONTHS THE MUSCLE SPASMS AND SHOCKING ARE CONSTANT, BUT THE STIMULATION MAKES THEM SYMPTOMS WORSE. THE PAIN IS SO BAD IT MAKES HER GRUNT. PATIENT IS ALSO EXPERIENCING FATIGUE. PSYCHIATRIST LOWERED SETTINGS BUT THAT HAS NOT HELPED WITH ANY SYMPTOMS. PATIENT FURTHER REPORTS SHE HAD A CHEST X-RAY AND AND CT DUE TO THE PAIN. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT IMPROVED ON DISCONTINUATION OF VNS STIMULATION BUT STILL EXPERIENCES ABDOMINAL AND SOME CHEST MUSCLE SPASMS. PATIENT ALSO REPORTS SPASM OR SHOCKS AND RESPONSES ALSO HAPPEN WITH INCREASED ANXIETY. THE PHYSICIAN MAY ADJUST ANXIETY MEDICINE AND OR TAPER OFF HER RISPERIDORE. THEY WERE ABLE TO DISCONTINUE OUTPUT CURRENT SUCCESSFULLY AND PATIENT REACTED WELL. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Chest Pain; Cramp(s) /Muscle Spasm(s); Extreme Exhaustion

  MAUDE report 15655335 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THEIR DEVICE DISABLED AND NOW REFERRED FOR REPLACEMENT DUE TO MUSCLE SPASMS ON THE LEFT SIDE OF HER NECK AND SHOULDER SEVERAL TIMES A DAY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 15384742 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT HER VNS HAS BEEN OFF FOR YEARS AND HAD OVERWORKED HER BODY. SHE NOTED THAT VNS HURT HER SYSTEM AS WELL. SHE SAID SHE COULD HEAR HER HEARTBEAT WHEN SHE TURNED HER HEAD. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 15348463 ↗
• MalfunctionMay 26, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PHYSICIAN HAS HAD TWO INCIDENTS WHERE HE PERFORMED TESTING ON A PATIENT'S DEVICE AND THEN PERFORMED A FINAL INTERROGATION TO CONFIRM THE PATIENT WAS PROGRAMMED TO INTENDED SETTINGS, BUT AT THE NEXT APPOINTMENT THE SETTINGS HAD SPONTANEOUSLY CHANGED. THIS MDR CAPTURES THE REPORT FOR ONE UNKNOWN PATIENT, MFR. REF # 1644487-2022-00624 CAPTURES THE REPORT FOR THE OTHER. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519158 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A GENERATOR REPLACEMENT OCCUR. SURGICAL NOTES WERE LATER RECEIVED INDICATING THE PATIENT WAS HAVING DAILY SEIZURES PRIOR TO THE GENERATOR REPLACEMENT. FOLLOW-UP CONFIRMED THE PATIENT WAS DOING AND FEELING WELL AFTER GENERATOR REPLACEMENT. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 13443154 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PRESENTED WITH REDNESS, SWELLING AND EXUDATION MONTHS AFTER HAVING THEIR VNS IMPLANTED AND WAS TAKEN TO THE HOSPITAL. THE PATIENT UNDERWENT SURGERY TO HAVE THE GENERATOR MOVED TO THE RIGHT SIDE OF THEIR CHEST AND IS BEING MONITORED FOR FURTHER OBSERVATION WITH ANTIBIOTIC TREATMENT. THE MANUFACTURER'S DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL FUNCTIONAL AND QUALITY SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION AND WAS CONFIRMED HP STERILIZED. THE PHYSICIAN BELIEVES THAT THE REDNESS, SWELLING AND EXUDATION ARE DUE TO THE PATIENT'S TOUCHING THE IMPLANT SITE, AND THEREFORE DURING RE-IMPLANT SURGERY THE PATIENT'S DEVICE WAS MOVED UNDER THEIR ARMPIT ON THE RIGHT SIDE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13359883 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN CLINIC NOTES THAT AFTER VNS PLACEMENT THE PATIENT HAD POSSIBLE SURGICAL SITE INFECTION AT THE GENERATOR POCKET AND REDNESS AROUND THE INCISION. IT WAS NOTED THAT NO FURTHER SURGERY WAS REQUIRED BUT THERE WAS QUESTIONABLE INFECTION AT THE TIME ALONG WITH A HYPERTROPHIC SCAR. IT IS NOTED THERE IS A LARGE KELOID AT HER INCISION SITE. 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 FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12935214 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT THERE WAS NO OTHER KNOWN CAUSE BESIDES LOW BATTERY FOR THE PATIENT'S SEIZURES BUT NOTED THAT HE HADN'T CHECKED THE DEVICE YET BEFORE REPORTING THAT IT HAD A LOW BATTERY.

  Patient problems: Convulsion, Clonic

  MAUDE report 12759711 ↗
• MalfunctionOct 25, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS NOTED THAT THE SUSPECT GENERATOR WAS DISCARDED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689848 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED GRANULATION TISSUE HYPERPLASIA FOLLOWING VNS IMPLANT AND HAD TO BE HOSPITALIZED AND HAVE AN ADDITIONAL SURGERY. THE GENERATOR HAD TO BE REPLACED DURING THIS SURGERY AS IT COULD NOT BE COMMUNICATED WITH, REPORTED IN MFR. REPORT # 1644487-2021-01480. IT WAS NOTED THAT THE PHYSICIAN THINKS THE CAUSE OF THE GRANULATION TISSUE HYPERPLASIA COULD BE DUE TO PATIENT PHYSIOLOGY AS THE PATIENT IS CONFIRMED AS ALLERGIC PHYSIQUE. IT IS NOTED THAT PATIENTS CAN BE ALLERGIC TO CERTAIN INGREDIENTS CONTAINED IN THE PRODUCT, OR POOR POSTOPERATIVE HEALING CAN LEAD TO REDNESS AND SWELLING THE WOUND SITE, WHICH MAY NOT NECESSARILY BE ALLERGIC. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE AND WAS CONFIRMED TO BE HP STERILIZED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Local Reaction

  MAUDE report 12689642 ↗
• DeathOct 1, 2021Adverse 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 LIKELY SUDEP, NOT BELIEVED TO BE RELATED TO VNS. THE EXPLANTED PRODUCTS WERE RECEIVED FOR ANALYSIS BUT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 12561843 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED VOCAL CORD PARALYSIS SUDDENLY, AND THERE WAS NO TRAUMA. IT RESOLVED OVER TIME WITH NO INTERVENTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 12542097 ↗

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-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-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-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.