VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05425025750528), received between Nov 13, 2023 and May 8, 2026 — classified as 4 deaths, 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Electrostatic Discharge” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

28 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.

Recalls naming this device

1. Jan 3, 2025Class IIOpen, Classified

   Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

   Z-1068-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 12, 2024Class IIOpen, Classified

   Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

   Z-1072-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT PRESENTED TO THE ER WITH AN SKIN ULCER AT THEIR GENERATOR SITE. THE PATIENT'S ULCER RUPTURED AT THE HOSPITAL EXPOSING THE PATIENT'S LEADS. THE PATIENT UNDERWENT SURGERY FOR WOUND CLEANING AND VNS REPOSITIONING TO ALLOW THE WOUND TO HEAL. THE PATIENT'S GENERATOR AND LEAD WERE NOT EXCHANGED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE PATIENT'S GENERATOR AND LEAD. THE DEVICES PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Impaired Healing; Pocket Erosion

  MAUDE report 25130069 ↗
• MalfunctionApr 20, 2026Premature Discharge of Battery; Electrostatic Discharge

  LATER, AN UPDATED WAS RECEIVED INDICATING THAT THE GENERATOR WAS REPLACED PROPHYLACTICALLY. IT WAS REPORTED THAT THE EXPLANTED GENERATOR WAS DISCARDED AND IS UNAVAILABLE FOR RETURN. NO CORRECTIVE ACTION IS NEEDED AS THERE IS NO NEW HARM OR RISK ESTABLISHED FOR THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932922 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. PATIENT FOLLOWED UP FOR SURGERY WHERE POCKET WAS CLEANED OUT AND GENERATOR WAS REMOVED; THE LEADS REMAIN INTACT. 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 24704565 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURE. FOLLOWING A REDUCTION IN SETTINGS AND CHANGE IN MEDICATION THE PATIENT BEGAN TO DUE BETTER. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 24649597 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR EXPLANT DUE TO AN INFECTION. PER THE SURGEON, THE PATIENT BEGAN TO PICK AT INCISIONS CAUSING THE INFECTION. THE DEVICE HISTORY RECORDS FOR THE GENERATOR WERE REVIEWED. THE GENERATOR WAS CONFIRMED TO HAVE BEEN HP STERILIZED PRIOR TO DISTRIBUTION INTO THE FIELD. THE DEVICE PASSED ALL SPECIFICATIONS, INCLUDING QUALITY CONTROL INSPECTION, AND SHOWED NO NON-CONFORMITIES, PRIOR TO ITS RELEASE INTO THE FIELD FOR DISTRIBUTION. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 23878100 ↗
• MalfunctionNov 17, 2025High impedance; Incomplete or Inadequate Connection; High impedance; Incomplete or Inadequate Connection

  ADDITIONAL INFORMATION RECEIVED. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT PIN RE-INSERTION SURGERY AND HIGH IMPEDANCE WAS RESOLVED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569142 ↗
• DeathSep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT'S DEATH IS NOT BELIEVED TO BE RELATED TO THE VNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063262 ↗
• DeathAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. IT WAS STATED BY THE PROVIDER THAT THE PATIENT HAD A SEIZURE IN THE MIDDLE OF THE EVENING AND HIT HIS HEAD. IT IS UNKNOWN WHAT THE CAUSE OF DEATH WAS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898984 ↗
• MalfunctionJul 1, 2025Fracture; High impedance; Incomplete or Inadequate Connection; Fracture; High impedance; Incomplete or Inadequate Connection

  PER THE PHYSICIAN, THE BOTTOM ELECTRODE LEAD WAS NOT SCREWED INTO PLACE, ONTO THE IPG SITE. THE PHYSICIAN NOTING "THE BOTTOM ELECTRODE LEAD WAS NOT SCREWED INTO PLACE ONTO THE IPG SITE" THIS WILL BE ASSESSED AS INCOMPLETE PIN INSERTION BEING THE CAUSE OF THE HIGH IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379500 ↗
• MalfunctionJun 25, 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 SINCE THEIR REPLACEMENT. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22327688 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE REPLACEMENT, THE PATIENT HAS HAD A SIGNIFICANT INCREASE IN SEIZURES. THE PATIENT ALSO REPORTED THAT THEY CAN NO LONGER PERCEIVE STIMULATION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AS A RESULT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22206816 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO ALTERED MENTAL STATUS AND SEIZURES. WHEN ASKED IF THE SEIZURES AND ALTERED MENTAL STATUS WERE BELIEVED TO BE RELATED TO VNS, THE MRI TECHNICIAN INDICATED THEY WERE UNSURE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 21998890 ↗
• DeathMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEATH FOLLOW-UP FORM WAS SENT TO THE PATENT'S MANAGING PHYSICIAN. THE COMPLETED FORM WAS FILLED OUT AND REVEALED THE FOLLOWING SURROUNDING THE EVENT: THE PHYSICIAN RE-ITERATES THAT THE PATIENT PASSED AWAY FROM STATUS EPILEPTICUS. THE PATIENT'S RESPONSE TO VNS THERAPY WAS A SEIZURE REDUCTION/SEIZURE FREE. BOTH THE GENERATOR AND LEAD WERE EXPLANTED AFTER DEATH AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. THE RELATIONSHIP OF DEATH TO THE VNS WAS DETERMINED TO BE NOT RELATED. WHEN THE PATIENT WAS FOUND DEAD, THEY WERE NOTED TO BE LAYING ON THE FLOOR WITH THEIR HEAD [ILLEGIBLE]. THE PATIENT DID HAVE A HISTORY OF NOCTURNAL SEIZURES.

  Patient problems: Status Epilepticus

  MAUDE report 21954149 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE INFECTION WAS AT THE GENERATOR SITE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21320915 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL EXPLANT DUE TO EXTRUSION OF THE GENERATOR AND INFECTION AT THE GENERATOR SITE. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pocket Erosion; Skin Infection

  MAUDE report 20726083 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN REFERRED FOR EXPLANT DUE TO AN INFECTION AND WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT'S GENERATOR WAS EXPLANTED DUE TO THE INFECTION AND WOUND DEHISCENCE. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO BE RELATED TO THE IMPLANT PROCEDURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 20694333 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD LEFT VOCAL CORD PARALYSIS AFTER A RECENT BATTERY REPLACEMENT AND PER THE PHYSICIAN, THE CAUSE IS UNCLEAR. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 20668842 ↗
• DeathSep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THE ESTIMATED DATE THAT PATIENT EXPERIENCED AN INCREASE IN SEIZURES. THE DATE OF DEATH WAS PROVIDED. SESSION REPORT RECEIVED. IN RESPECT OF REACHING OUT TO THE CORONER AND THE PHYSICIAN FOR THE CAUSE OF DEATH AND INCREASED SEIZURES, THE LOCAL REP IS UNABLE TO DO THIS AS THIS IS DEEMED AS CONFIDENTIAL INFORMATION. THE DEVICE HAS SHIPPED. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic; Insufficient Information

  MAUDE report 20324318 ↗
• MalfunctionAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS RECENTLY BEEN EXPERIENCING INCREASED SEIZURES AND HAS A FOLLOW UP APPOINTMENT WITH HIS PHYSICIAN IN THE NEAR FUTURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 20089217 ↗
• MalfunctionAug 20, 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 SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 20001572 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR GENERATOR EXPLANTED WITH A WOUND REVISION/WASHOUT 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: Post Operative Wound Infection

  MAUDE report 19386920 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FIRST HOSPITALIZED AND THEN ULTIMATELY EXPLANTED DUE TO FEVER, DEHISCENCE WOUND, AND DRAINAGE. NO ASSESSMENT COULD BE PROVIDED BY PHYSICIAN AS TO IF THERE WAS AN INFECTION PRESENT. 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. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO BE RELATED TO THE FUNCTIONALITY OF THE DEVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 19096396 ↗
• MalfunctionMar 29, 2024Premature Discharge of Battery; Failure to Interrogate; Electrostatic Discharge; Premature Discharge of Battery; Failure to Interrogate; Electrostatic Discharge

  IT WAS REPORTED THAT GENERATOR INTENDED TO BE IMPLANTED IN THE PATIENT WAS UNABLE TO BE INTERROGATED. TROUBLESHOOTING WAS ATTEMPTED, EFFORTS WERE MADE TO REDUCE EMI, HOWEVER THE GENERATOR WAS STILL UNABLE TO BE INTERROGATED AFTER SEVERAL ATTEMPTS. THE SURGEON OPTED TO IMPLANT A DIFFERENT GENERATOR WHICH WAS IMPLANTED AND SUCCESSFULLY INTERROGATED. DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE WAS SEEN TO PASS ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. THE DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004338 ↗
• MalfunctionMar 29, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S GENERATOR COULD NOT BE INTERROGATED A COUPLE MONTHS AFTER IMPLANT. PROGRAM SYSTEM ISSUES/ELECTROMAGNETIC INTERFERENCE, AND IMPLANT DEPTH HAS BE RULED OUT. WHEN ATTEMPTING TO INTERROGATE THE DEVICE "CANNOT DETECT THE GENERATOR" MESSAGE IS SEEN. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003618 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR SYSTEM REMOVAL DUE TO WOUND DEHISCENCE. NO KNOWN RELEVANT 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; Impaired Healing; Wound Dehiscence

  MAUDE report 18912752 ↗

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-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-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• 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
• Z-0659-2016 · Dec 18, 2015 · Terminated
  VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
• Z-0645-2016 · Nov 18, 2015 · Terminated
  Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

…and 13 more.