VNS Therapy® PerenniaDURA® Model 303 Lead 303-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05425025750122), received between Apr 13, 2018 and Oct 30, 2025 — classified as 15 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Low impedance; Electrical Shorting; Low impedance; Electrical Shorting

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH LOW LEAD IMPEDANCE AND IS IN NEED OF A REVISION. 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 23424770 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S LEAD IS PROTRUDING FROM THEIR NECK AND HAS NOW CAUSED A STAPH INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT IS EXPERIENCING PARALYSIS NEAR THE VAGUS NERVE DUE TO IMPROPER STITCHING TECHNIQUE. THE PATIENT WAS REFERRED FOR SURGERY TO ADDRESS THE ISSUE. PRODUCT RETURN AND PRODUCT ANALYSIS IS WILL NOT BE CONSIDERED AS SUPPLEMENTAL AS THE ADVERSE EVENTS REPORTED DOES NOT RESULT FROM 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 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; Paralysis; Post Operative Wound Infection

  MAUDE report 22722872 ↗
• MalfunctionJul 25, 2025Low impedance; Electrical Shorting; Low impedance; Electrical Shorting

  DURING A PERIODIC PROGRAMMING HISTORY DATABASE REVIEW, LOW LEAD IMPEDANCE WAS OBSERVED TO HAVE BEEN SEEN ON (B)(6) /2023 FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED NOTING THAT ON 4/2/2025 THE IMPEDANCE CORRECTED TO NORMAL AND CHEST X-RAYS WERE ORDERED. ON (B)(6) 2025 THE X-RAY REPORT NOTED, "VNS DEVICE PROJECTS OVER THE LEFT CHEST WALL AND CURVES UP THE LEFT NECK". THE PATIENT WILL BE RE-EVALUATED DURING THEIR NEXT FOLLOW-UP VISIT ON (B)(6) 2025.. NO KNOWN 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 22620868 ↗
• MalfunctionJul 9, 2024High impedance; High impedance

  A TIMESTAMP DISCREPANCY WAS LATER IDENTIFIED IN THE DECODER CREATED DURING PRODUCT ANALYSIS (PA) WHERE HIGH IMPEDANCE OCCURRED PRIOR TO DEVICE IMPLANT. THIS IS A RESULT OF THE DEVICE BEING AT COMPLETE END OF SERVICE (EOS) IN PA, REQUIRING AN EXTERNAL POWER SOURCE TO POWER THE DEVICE. THIS RESULTS IN THE GENERATOR'S INTERNAL CLOCK (EPOCH TIME) CHANGING FROM IT'S ORIGINAL SET DATE. THE HIGH IMPEDANCE IN THIS REPORT OCCURRED PRIOR TO DEVICE IMPLANT THEREFORE SHOULD NOT HAVE BEEN CAPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700141 ↗
• MalfunctionDec 5, 2023High impedance; High impedance

  THE PATIENT HAD THEIR VNS EXPLANTED DUE TO UNKNOWN REASONS AND THE GENERATOR AND LEAD WERE RETURNED AND UNDERWENT PRODUCT ANALYSIS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. BUT WHILE REVIEWING THE DATA DUMP IT WAS REVEALED THAT HIGH IMPEDANCE WAS SEEN ON (B)(6) 2020. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270720 ↗
• MalfunctionJul 27, 2023High impedance; High impedance

  PRODUCT ANALYSIS WAS APPROVED AND COMPLETED. AN INTERROGATION, SYSTEM DIAGNOSTIC TESTS, AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN INTENSIFIED FOLLOW-UP INDICATOR=NO CONDITION) WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS WORKSHEET WAS REVIEWED AND NO ANOMALIES WERE SEEN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405883 ↗
• MalfunctionJun 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION DUE TO HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105551 ↗
• InjuryNov 14, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING SOME ABNORMAL SENSATION DURING NORMAL VNS STIMULATION. THE PATIENT EXPLAINED A "SHARPER" FEELING THAT NOW RADIATED UP TO HER EAR, WHICH USED TO BE ONLY A "SHARP/SHOCKING" FEELING IN THE NECK, BUT HAS SINCE MOVED UP AND BECOME INCREASINGLY UNCOMFORTABLE. AN ATTEMPT WAS MADE TO THE MEDICAL PROFESSIONAL FOR ADDITIONAL INFORMATION AND A RESPONSE WAS RECEIVED PROVIDING THE PATIENT'S NAME AND NOTED THE IMPEDANCE WAS WITHIN NORMAL LIMITS. IT WAS LATER REPORTED THAT IN 2019, PATIENT DEVELOPED PAIN IN ANTERIOR ASPECT OF HIS NECK, DIFFICULTY SWALLOWING, AND DYSPHONIA. HE WAS SUBSEQUENTLY DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS FOLLOWING ENT SCOPE EVALUATION. HIS VNS HAS BEEN TURNED OFF SINCE THAT TIME. PROGRAMMING HISTORY WAS REVIEWED AND SHOWED DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS WHEN DEVICE WAS DISABLED DUE TO THE ADVERSE EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 15788483 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS COMPLAINING OF PAIN IN HER NECK, AS A BURNING SENSATION. SHE ALSO COMPLAINED OF THE LEAD PROTRUDING UNDER HER SKIN. THE PATIENT IS REFERRED FOR VNS REMOVAL. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

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

  MAUDE report 12773839 ↗
• MalfunctionNov 7, 2021High impedance; Incomplete or Inadequate Connection; High impedance; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO CORRECT THE HIGH IMPEDANCE. THE PIN WAS REMOVED CLEANED AND REINSERTED AND HIGH IMPEDANCE RESOLVED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758695 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REFERRED TO SURGERY TO HAVE THEIR LEAD LOOSENED DUE TO REPORTED TIGHTNESS WHEN TURNING THEIR HEAD. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Neck Pain

  MAUDE report 12739691 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESPONSE WAS RECEIVED FROM THE PHYSICIAN THAT THERE IS NO SUSPECTED MIGRATION PRESENT AND THAT THE PAIN IS POSSIBLY RELATED TO JUST THE PRESENCE OF THE DEVICE FROM THE FALL. THE PHYSICIAN CONFIRMED THAT THE PRODUCT WAS SECURED DURING INITIAL IMPLANT. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Code Available; Pain

  MAUDE report 11266921 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS VNS SYSTEM EXPLANTED DUE TO SKIN BREAKDOWN AROUND THE SURGICAL SITE FOR THE LEAD AND TRACHEOSTOMY SITE. DEVICE HISTORY RECORDS FOR THE LEAD AND GENERATOR WAS REVIEWED AND BOTH DEVICES WERE CONFIRMED HP STERILIZED PRIOR TO DISTRIBUTION. INFORMATION WAS RECEIVED THAT THE PATIENT DID HAVE CONFIRMED INFECTION. IT WAS ALSO NOTED THAT THE LEADS AND ANCHORS WERE BOTH EXPOSED. THE PHYSICIAN ALSO NOTED THAT THE TRACH TIES (FOR THE TRACHEOSTOMY) AT THE NECK WAS THE BELIEVED CAUSE OF THE ISSUE AS WELL AS PRIOR OPEN WOUND AT THE CHEST THAT WAS NOT TREATED IN MARCH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 10213487 ↗
• MalfunctionApr 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S ELECTRODES HAVE COME OFF THE NERVE AND APPEAR TO BE HORIZONTAL AS OPPOSED TO VERTICAL. PATIENT IS EXPERIENCING NECK PAIN. THE AREA WAS TENDER BUT NOT RED. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9928352 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REPORTED TO BE REFERRED FOR SURGERY DUE TO THE LEAD BEING TOO TIGHT AND PULLING WHEN THE PATIENT TURNS HIS HEAD. IT WAS NOTED THAT DURING THE SURGERY THE LEAD WIRE WOULD BE LOOSENED IN THE NECK AND CHEST AREA. IT WAS NOTED THAT PRODUCT REPLACEMENT WAS NOT EXPECTED. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Code Available; Pain

  MAUDE report 9488395 ↗
• MalfunctionDec 9, 2019Low impedance; Low impedance

  GENERATOR AND LEAD WERE EXPLANTED. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9438951 ↗
• MalfunctionDec 6, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVED A "CLICKING STIMULATING OF A SHORT BURST IN HER LEFT CHEST REGULARLY ALTHOUGH NOT SEVERE PAIN." IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS PROPHYLACTICALLY REPLACED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS TO DATE. IT WAS REPORTED THAT THE PATIENT'S GENERATOR EXHIBITED LOW IMPEDANCE WHICH WAS CORRECTED BY UNTANGLING THE LEAD AND REPLACING THE GENERATOR. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pain

  MAUDE report 9434088 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S OFFICE THAT THE VOCAL CORD PARALYSIS WAS DISCOVERED FOLLOWING SURGERY PER THE PATIENT. THE VOCAL CORD PARALYSIS IS INDICATED TO BE DUE TO SURGERY AND THE HOARSENESS BEGAN AFTER THE SURGERY BEFORE STIMULATION WAS TURNED ON. IT WAS INDICATED THAT THE PATIENT HAS ONLY HAD 2 VNS SURGERIES. BASED ON WHEN THE EVENT WAS REPORTED AND WHEN THE LAST SURGERY OCCURRED, IT IS LIKELY THE REPORTED VOCAL CORD PARALYSIS WAS RELATED TO THE REVISION SURGERY THAT OCCURRED DUE TO THE LEAD ISSUE REPORTED IN MFR. REPORT #1644487-2019-01733. LAST PROGRAMMED SETTINGS AND DIAGNOSTICS WERE PROVIDED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 9362398 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN'S OFFICE REPORTED THAT AT THE TIME THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE CHEST PAIN HE WAS HAVING MUSCLE TWITCHING ON BOTH SHOULDERS DUE TO STIMULATION AS ASSESSED BY THE PHYSICIAN. THIS WAS DETERMINED AFTER THE DEVICE WAS SWITCHED OFF AND THE PATIENT REPORTED FEELING A DIFFERENCE IN THE SPASMS. WHEN THE PATIENT WAS REFERRED TO THE SURGEON FOR EVALUATION OF THESE ISSUES, THE SURGEON DECIDED A SURGERY WAS NEEDED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Chest Pain; Muscle Spasm(s)

  MAUDE report 9265656 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SENSATION OF DYSPNEA WHILE SPEAKING AND HOARSENESS. WHEN SEEN BY OTOLARYNGOLOGY, IT WAS NOTED THAT THE PATIENT HAS LEFT VOCAL PARESIS AND HAD AN INJECTION IN THE VOCAL FOLD. IT WAS STATED THAT THE PATIENT HAS HAD PREVIOUS NECK TRAUMA AND HAD TO BE TRACHED AFTER AN ACCIDENT DUE TO A SEIZURE, PRIOR TO VNS PLACEMENT. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Dyspnea; Paresis

  MAUDE report 8732750 ↗
• MalfunctionMay 10, 2019Fracture; Fracture

  INFORMATION WAS RECEIVED THAT HIGH IMPEDANCE >9000 OHMS WAS SEEN ON THE PATIENT¿S M1000 GENERATOR. THIS IS LIKELY A CONTINUATION OF THE PATIENT¿S PAST FLUCTUATING HIGH IMPEDANCE SINCE THE AFFECTED LEAD IS STILL IMPLANTED IN THE PATIENT. NO KNOWN SURGICAL INTERVENTION FOR THE LEAD HAS OCCURRED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8600484 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEAD AND GENERATOR REPLACEMENT. THE REASON FOR GENERATOR REPLACEMENT WAS INDICATED AS PROPHYLACTIC. THE EXPLANT FACILITY HISTORICALLY DISCARDS EXPLANTED PRODUCTS; THEREFORE, THE RETURN OF THE SUSPECT DEVICE IS NOT EXPECTED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pain

  MAUDE report 8574755 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEUROLOGIST REPORTED THAT HE VISIBLY COULD SEE AND FEEL STIMULATION ON A PATIENT¿S NECK. THE NECK WAS SEEN TO BE VIBRATING. DIAGNOSTICS WERE OK. THE NECK WOULD VIBRATE A COUPLE TIMES DURING THE DAY, AND DID NOT OCCUR WITH EVERY STIMULATION. THE PATIENT HAD NOTED IT TO BE ANNOYING AND UNCOMFORTABLE. THE PHYSICIAN WAS NOT SURE IF IT WAS MUSCLE SPASMS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN ALLERGIC REACTION TO A MEDICATION IN DECEMBER AND WAS INTUBATED FOR FOUR DAYS. SINCE THAT TIME SHE HAS HAD PAINFUL STIMULATION THAT IS PALPABLE THROUGH THE SKIN OF HER NECK. SHE ALSO REPORTS SHORTNESS OF BREATH. SHE INDICATED THAT THE SETTINGS WERE RE-ADJUSTED 8 WEEKS AGO, BUT SHE IS CONTINUING TO EXPERIENCE UNCOMFORTABLE STIMULATIONS, STIMULATIONS THAT ARE PALPABLE THROUGH THE SKIN, SHORTNESS OF BREATH, AND PALPITATIONS. CLINIC NOTES WERE RECEIVED THAT THE IS REFERRED FOR LEAD REPLACEMENT. NOTES STATE PATIENT IS STILL HAVING 30 OR MORE PAINFUL STIMULATIONS A DAY AND THEY HAVE DISCUSSED REPLACING LEADS. NOTES STATE THAT THEY NEED TO CHECK THE LEAD AS IT HASN¿T BEEN THE SAME SINCE SHE WAS INTUBATED. REGARDING SHORTNESS OF BREATH NOTES STATE DOING WELL CURR

  Patient problems: Dysphagia/ Odynophagia; Dyspnea; Muscle Spasm(s)

  MAUDE report 8552815 ↗
• MalfunctionApr 9, 2019Fracture; Fracture

  EXPLANTED GENERATOR WAS RECEIVED BY PRODUCT ANALYSIS. PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. FURTHER INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT PIN RE-INSERTION WAS NOT ATTEMPTED DURING SURGERY AND THAT THE LEAD WAS NOT REPLACED AS IMPEDANCE WAS OK AFTER GENERATOR REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496049 ↗
• MalfunctionDec 10, 2018High impedance; High impedance

  PATIENT UNDERWENT GENERATOR AND LEAD REVISION SURGERY. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149386 ↗

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-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-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.