VNS Therapy® Pulse Duo Model 102R GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05425025750023), received between Dec 14, 2017 and May 16, 2025 — classified as 1 death, 24 injuries, 10 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. 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD BEEN SHUT OFF BECAUSE THE MOTHER THOUGHT IT WAS WORSENING HER SEIZURES. THEY PLAN TO DO A BATTERY CHANGE FOR THE PURPOSE OF USING AUTOSTIM AND MAGNET MODE, WITH NORMAL MODE TO BE SET TO 0 MA. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22040717 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  LATER, ANALYSIS OF THE GENERATOR WAS COMPLETED IN WHICH THE CAUSE OF THE HIGH IMPEDANCE WAS IDENTIFIED. IT WAS DETERMINED THAT THE FEED-THRU WIRE IN THE GENERATOR HEAD WAS FRACTURED. THE SUSPECT PRODUCT HAS BEEN UPDATED TO THE GENERATOR. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052211 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY THE PHYSICIAN THAT THE DEVICE WAS DISABLED DUE TO THE PATIENT UNABLE TO TOLERATE THEIR PREVIOUS SETTINGS IN (B)(6) 2023. THE PATIENT WAS THEN EXPERIENCING AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE LEVELS AND WAS NOTED TO BE DUE TO THE LACK OF VNS STIMULATION IN (B)(6) 2023, AS DEVICE HAD BEEN INTENTIONALLY PROGRAMMED OFF. IT WAS ALSO NOTED THAT THE EXPRESSED SUICIDAL IDEATION WITH INTENTIONS OF TAKING OTHER WITH HIM WAS DUE TO HIM FEELING MISERABLE. SPECIFICALLY, HE WAS EXPERIENCING AN INCREASE IN SEIZURES FROM A LACK OF VNS STIMULATION. THEREFORE, THE CAUSE OF THE SUICIDAL AND HOMICIDAL IDEATIONS CAN BE CONCLUDED TO BE LACK OF VNS STIMULATION. THE DEVICE WAS NOTED TO BE RE-ENABLED IN (B)(6) 2023 AND THAT THE PATIENT IS TOLERATING THESE PROGRAMMED SETTINGS. ALONG WITH THIS, THE BATTERY STATUS WAS FOUND AT END OF SERVICE AND PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic; Suicidal Ideation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 18292114 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT PATIENT HAD A BATTERY REPLACEMENT. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 18086385 ↗
• InjurySep 11, 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 17719472 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY.

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

  MAUDE report 17513293 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HOSPITALIZED DUE TO INCREASED SEIZURES THAT DO NOT RESPOND TO MEDICATION. THE SEIZURES WERE SUSPECTED TO BE DUE TO LOW BATTERY. THE DEVICE WAS CHECKED AND THE BATTERY WAS FOUND TO BE OK. THERE WAS NO HISTORY OR ANY TRAUMA AND THERE WERE NO CHANGES TO THE PATIENT'S MEDICATIONS PRIOR TO THE START OF THE INCREASED SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 17117558 ↗
• DeathMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PASSED AWAY. THE PHYSICIAN'S OFFICE LATER REPORTED THAT THE PATIENT'S DEATH IS NOT RELATED TO SEIZURES OR VNS, SHE WAS DECLINING IN HEALTH IN A SKILLED FACILITY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16606076 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IN THE ICU AND WHEN THE NURSE PRACTITIONER WENT TO INTERROGATE THE DEVICE TO RUN DIAGNOSTICS AND THE PATIENT EXPERIENCED ASYSTOLE. THE NP IMMEDIATELY STOPPED THE INTERROGATION, SO IMPEDANCE VALUE UNKNOWN. OVER THE NEXT FEW HOURS, THE PATIENT HAD BEEN EXPERIENCING ASYSTOLE EVERY HOUR. IT WAS LATER REPORTED THAT PER THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF ASYSTOLE IS RELATED TO VNS STIMULATION. THE PATIENT WAS IN THE HOSPITAL DUE TO OTHER ISSUES WHICH WERE POSSIBLY RELATED TO SEVERE COVID SYMPTOMS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 15814407 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ER WITH INCREASED SEIZURES. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 13736457 ↗
• MalfunctionDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INCREASE IN SEIZURES WERE REPORTED FOR THE PATIENT. THE PHYSICIAN PERFORMED DIAGNOSTICS AND ALL VALUES WERE WITHIN NORMAL LIMITS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 13025040 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION OBTAINED THAT THE SURGICAL FACILITY'S POLICY IS TO DISCARD ALL EXPLANTS, SO PRODUCT RETURN IS NOT EXPECTED.

  Patient problems: Convulsion, Clonic

  MAUDE report 12487730 ↗
• MalfunctionJul 20, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IMPLANT CARD WAS RECEIVED THE PATIENT RECEIVED A REPLACEMENT DUE TO BATTERY DEPLETION. THE HOSPITAL THE REPLACEMENT TOOK PLACE DOES NOT RETURN EXPLANTED PRODUCTS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic; No Clinical Signs, Symptoms or Conditions; Sleep Dysfunction

  MAUDE report 12196246 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING AN INCREASE IN SEIZURES AND MOTHER BELIEVES IT TO BE RELATED TO BATTERY DEPLETION. BATTERY WAS CHECKED AND IMPEDANCE WAS NOTED TO BE OK AND BATTERY OK. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 11998744 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A GENERATOR REPLACEMENT OCCUR. THE EXPLANTED PRODUCT WAS DISCARDED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 11975157 ↗
• MalfunctionFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT A FOLLOW UP APPOINTMENT, THE PATIENT HAD SYSTEM DIAGNOSTICS PERFORMED. IT WAS NOTED THAT THE PATIENT WAS PREVIOUSLY PROGRAMMED TO 0.25 MA OUTPUT CURRENT FOR TOLERABILITY REASONS, AND THEREFORE THE SYSTEM DIAGNOSTICS BEING PERFORMED AT 1 MA WAS HIGHER STIMULATION THAN THE PATIENT COULD TOLERATE. DIAGNOSTICS WERE REPORTED TO BE WITHIN NORMAL LIMITS. THE PATIENT WENT HOME FOLLOWING THE APPOINTMENT AND REPORTED PAIN IN THE NECK AND THROAT, AS WELL AS AN INCREASE IN SEIZURES. UPON REINTERROGATION, THE PATIENT'S VNS SETTINGS WERE FOUND TO BE SET TO THE PARAMETERS AT WHICH SYSTEM DIAGNOSTICS ARE RUN, INDICATING THAT THE SETTINGS WERE HIGHER THAN WHAT THE PATIENT COULD TOLERATE. PER THE PHYSICIAN, THE SETTINGS WERE CHECKED AFTER THE INITIAL APPOINTMENT AND WERE VERIFIED TO BE AT THE INTENDED SETTINGS, SO THE SETTINGS CHANGE WAS UNEXPECTED. THE SETTINGS CHANGE WAS LIKELY DUE TO FAULTED DIAGNOSTICS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 11287873 ↗
• MalfunctionJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC NOTES WERE RECEIVED AND IT WAS REPORTED THAT THE PATIENT HAD THEIR SETTINGS ADJUSTED DUE TO AN INCREASE IN SEIZURES OVER THE PREVIOUS YEAR. IT WAS NOTED THAT THE PATIENT SEIZURES HAVE BEEN SHORTEN BY VNS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 11139911 ↗
• MalfunctionDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON NOTING THAT IT IS UNUSUAL FOR THE PATIENT TO HAVE DEVELOPED INTRACTABLE COUGHING AFTER HAVING THE DEVICE IMPLANTED FOR SO LONG. THERE IS SUSPECT OF THE PATIENT EXPERIENCING HEMI-LARYNGOPHARYNGEAL SPASM, BUT THIS HAS NOT BEEN CONFIRMED TO DATE. THERE WERE NO ABNORMALITIES FOUND IN THE PATIENT'S LAST MRI SCAN TO SUPPORT THIS DIAGNOSIS, BUT THE PATIENT WILL HAVE A MORE RECENT SCAN DONE TO FURTHER INVESTIGATE. THE EFFICACY OF THE DEVICE CANNOT BE DETERMINED AT THIS TIME AS WHEN THE DEVICE IS ON THE PATIENT IN UNABLE TO TOLERATE STIMULATION AND WOULD PREFER FOR THE DEVICE TO REMAIN OFF AT THIS TIME.

  Patient problems: Dyspnea; Seizures; Vomiting

  MAUDE report 11020248 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ALLEGING THE INCREASE IN SEIZURES AGAINST VNS. THE PATIENT REPLACEMENT WAS PROPHYLACTIC AND THERE WAS NO INDICATION THE PHYSICIAN BELIEVES VNS CONTRIBUTED TO THE INCREASED SEIZURES. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 10868570 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SURGERY TO HAVE THEIR VNS DEVICE REMOVED. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED AND PRODUCT ANALYSIS IS STILL UNDERWAY.

  Patient problems: No Code Available; Pain

  MAUDE report 10836925 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S MOTHER THE PATIENT WAS HAVING AN INCREASE IN SEIZURES. IT WAS REPORTED THAT THE PATIENT BATTERY WAS RUNNING LOW. A BATTERY CALCULATION ESTIMATED THAT THE BATTERY WAS LIKELY AT EOS AND NO LONGER STIMULATING. IT WAS REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT. THE EXPLANTED GENERATOR WAS RETURNED. PRODUCT ANALYSIS WAS CONDUCTED AND THE DEVICE WAS FOUND TO HAVE NOT REACH END OF SERVICE AND WAS ABLE TO PROVIDE STIMULATION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures

  MAUDE report 10289882 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE NEUROLOGIST THAT THE PATIENT'S FATHER INDICATED THAT THE PATIENT DID NOT SPEAK FOR A WEEK FOLLOWING PREVIOUS GENERATOR REPLACEMENT SURGERY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 8744453 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER FOLLOW UP WITH THE PHYSICIAN'S OFFICE CONFIRMED THAT THE PATIENT'S INCREASED SEIZURES WERE ABOVE PRE-VNS LEVELS AND THAT THE BELIEVED ROOT CAUSE FOR THE INCREASED SEIZURES WAS A DEPLETED BATTERY. IT WAS NOTED THAT TO CORRECT THE ISSUE OF INCONSISTENT STIMULATION THE PATIENT HAD TO UNDERGO BATTERY REPLACEMENT. THE FACILITY PROVIDED PROGRAMMING DATA, WHICH DID NOT SUPPORT A DEPLETED BATTERY CONDITION AS OF 05/13/2019. ADDITIONALLY, THE PATIENT'S VNS GENERATOR HAD BEEN PROGRAMMED OFF SINCE 04/25/2019 DUE TO THE REPORTED ERRATIC STIMULATION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Seizures; Undesired Nerve Stimulation

  MAUDE report 8623571 ↗
• MalfunctionApr 26, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT A PATIENT HAS AN M102R AND IT REPORTEDLY RESET TO 60 MIN OFF. PROGRAMMING HISTORY WAS RECEIVED AND REVIEWED. HISTORY SHOWED THAT THE PATIENT WAS INTERROGATED AT AN OUTPUT CURRENT OF 1.75MA ON (B)(6) 2019 WITH AN OFF TIME OF 60 MINUTES AND WAS PREVIOUSLY AT AN OUTPUT OF 1.5MA ON (B)(6) 2019 AND AN OFF TIME OF 0.8 MINUTES. THERE IS NO PROGRAMMING EVENT TO SHOW HOW THE PATIENT'S SETTING WERE CHANGED AND IT IS UNCLEAR IF THE PATIENT SAW A DIFFERENT PHYSICIAN DURING THE TIME BETWEEN THE FEBRUARY APPOINTMENT AND APRIL APPOINTMENT WHERE SETTINGS MAY HAVE BEEN ADJUSTED. OTHER THAN THE NOTED EVENTS, THERE ARE NO OTHER ANOMALIES WITHIN THE PROGRAMMING HISTORY. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554637 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS SEEN IN THE OFFICE AND IT WAS OBSERVED THAT THE GENERATOR HAD EXTRUDED AND NEEDED REPLACEMENT. THE PATIENT WAS GOING TO SEE THE SURGEON AS SOON AS POSSIBLE. IT WAS STATED THAT THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE EXTRUSION AND THAT THE DEVICE WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL, RELEVANT INFORMATION WAS RECEIVED TO DATE.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 8458805 ↗

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-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-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.