Vanta™ AdaptiveStim™ 977006 (UDI 00763000411923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,151 adverse event reports that list this exact device (DI 00763000411923), received between Aug 16, 2021 and Sep 28, 2026 — classified as 495 injuries, 656 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (181 reports).

3 FDA recall records name this device's identifier, 3 still open.

9 other recalls cover devices cleared under the same FDA submission (P840001); 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.

Recalls naming this device

1. Aug 21, 2024Open, Classified

   Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

   Z-0132-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Jun 6, 2023Open, Classified

   A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

   Z-2036-2023 · Root cause: Device Design · FDA record ↗

3. Mar 30, 2022Open, Classified

   The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

   Z-1123-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,151 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Break; Migration or Expulsion of Device; Impedance Problem

  It was reported that during implantable neurostimulator (INS) relocation and replacement, the existing leads migrated downward by two vertebral levels after being pulled through the skin to obtain additional slack. X-ray imaging performed during the procedure ide ntified the lead migration. One existing lead had an electrode with no connection when inserted into the new INS. Both existing leads were removed and replaced with new leads, and the existing INS was replaced. The device revision was completed successfully, and the issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915680 ↗
• InjurySep 28, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915615 ↗
• InjurySep 25, 2026Overheating of Device; Insufficient Device Problem Information

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator. The reason for call was rep states the patient is complaining of heat, tingling, and burning at the pocket site of their generator over the past 2-3 months. Representative stated this happens 2-3 times per week and the patient turns the stimulation off and it is better for 20 minutes and then when they turn it back on, it doesn't happen for a few days. Representative asked if it sounds like it's hitting a nerve and if the patient has had any falls or car accidents and if they turn the stimulation up or down and they said no. Representative also asked if there is anything different at those times like their activity or pressing against anything and patient said no, nothing had changed. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Agent advised having the patient keep a diary of when they experience this sensation prior to meeting with someone.

  Patient problems: Burning Sensation; Paresthesia

  MAUDE report 50900360 ↗
• InjurySep 25, 2026High impedance

  Information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (INS). It was reported that high impedances were observed on the day of surgery. Impedances were at 40,000 for all electrodes 0-15. Additional information was received from a manufacturer representative (rep). It was reported that the lead was not removed. The patient was only consented and consented for a battery replacement. The battery had reached End of Service (EOS). The lead remains implanted and the surgeon stated they need insurance approval for a lead revision. It was unknown if there were any external/environmental/patient factors that may have caused or contributed to the high impedances. The patient was asked if they had any falls or anything happened that may have caused the high impedances and the patient stated there were no falls or anything. The rep stated the battery will be shipped out and the lead remains implanted and will be returned after the lead revision.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896323 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from an HCP regarding an implantable neurostimulator.  Caller stated that the patient has not been using the device because they were getting shocks when it was working. Caller did not know the exact date when the shocking started, but the patient said it had been a while ago.

  Patient problems: Electric Shock

  MAUDE report 50885274 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810655 ↗
• InjuryAug 31, 2026High impedance

  It was reported that during a replacement of the battery involving an implantable neurostimulator, a connectivity check was performed after connecting the new battery and all electrodes showed ¿red X¿s,¿ indicating connectivity issues. A WENS check was then performed to determine whether the issue was related to the leads versus the new battery, and the leads showed the same connectivity issues with the WENS. The leads were reported as fractured, damaged, or broken and not working. The physician explanted the leads that were not working and implanted two new leads. After implantation of the new leads, a repeat connectivity check showed all electrodes were ¿green¿ and working. The patient was reported alive with no injury, and the issue was reported as resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware. Additional information was received from the manufacturer representative (rep). It was reported that the rep clarified that the report of the leads being broken was regarding the high impedance red x's being shown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101631 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  The reason for call was patient (pt) reported that right after the implant they started feeling "so much pain it was shocking" them all the time. Pt mentioned the representative made adjustments to the therapy "4 times" but nothing worked. Pt mentioned the implant was removed "a little over a year", "it was last year".

  Patient problems: Pain

  MAUDE report 50408943 ↗
• MalfunctionAug 11, 2026Premature Discharge of Battery; Failure to Interrogate; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208557 ↗
• MalfunctionAug 6, 2026Disconnection; High impedance; Migration or Expulsion of Device; Insufficient Device Problem Information

  Information was received from a patient's representative regarding an implantable neurostimulator. The reason for call was caller reported the patient was having severe pain. Caller stated the patient had a back injection that was part of trying to help the patient's back pain on August 5th and before that the patient started having to take oxycodone again. Patient was taking oxycodone because they weren't getting relief from the stimulator because it wasn't working. Patient saw a Dr. 'Person' on (B)(6) and it was determined that one of the leads was loose and not connected anymore. Agent redirected caller to the patient's HCP to address the issue.

  Patient problems: Pain

  MAUDE report 50157327 ↗
• InjuryAug 4, 2026Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area

  It was reported that the patient experienced return of pain with discomfort, soreness, and pinching, along with chest wall irritation following lead migration or dislodgement and stimulation in an undesired location. It was further reported that a device revision was performed in which both leads and the implantable pulse generator were replaced, and the leads were repositioned more midline to avoid chest wall irritation. The issue was reported as resolved, and the patient was reported alive with no injury. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Discomfort; Pain

  MAUDE report 50128497 ↗
• InjuryJul 30, 2026Malposition of Device

  It was reported that a patient with an implanted LEAD (b)(6) SPECIFY SURESCAN magnetic resonance imaging (MRI) 2X8 alleged that a paddle lead was not placed correctly and needed to be moved more to the left for coverage purposes. The patient reported a return of pain. The issue was reported as ongoing and not resolved. No serious adverse outcomes were reported. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Pain

  MAUDE report 50084680 ↗
• InjuryJul 29, 2026Energy Output Problem; Electromagnetic Compatibility Problem; Patient Device Interaction Problem

  It was reported that a patient with a pain stimulation implantable pulse generator (IPG) contacted support about issues with the spinal cord stimulator communicator, including rapid battery drain, poor charging performance, and erratic battery level indications. The patient stated the communicator battery dropped from 75% to 15% by the next day, and that after being plugged in for several hours the charge increased only from 15% to 45%, followed by unexpected jumps in the displayed battery percentage from 45% to 75% and then to 100%. The patient also reported that the communicator decreased from 100% to 90% while not in use. The patient stated they had received multiple communicator replacements, describing three communicators over three years and two replacement communicators already. The patient reported that when stimulation was on they could not lie flat and that stimulation ¿went nuts¿ when lying flat, and they reported turning stimulation off at night due to this. The patient expressed concern that if the communicator battery died at night, they would be unable to turn stimulation off and would be unable to lie down. The patient reported interference between deep brain stimul

  Patient problems: Pain

  MAUDE report 50071797 ↗
• InjuryJul 10, 2026Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR THE CALL WAS TO REPORT THAT THE PT WAS HAVING ISSUES CONNECTING TO THE THERAPY APP TO TURN THEIR INS OFF. CALLER STATED THAT THEY WERE PROMPTED TO PAIR THE COMMUNICATOR TO THEIR HANDSET BUT WAS UNABLE TO SUCCESSFULLY DO SO. CALLER ALSO EXPLAINED THAT THEY WERE "ZAPPED ALL NIGHT" BECAUSE THEY WERE UNABLE TO TURN STIMULATION OFF PRIOR TO GOING TO SLEEP FOR THE NIGHT. AGENT ATTEMPTED TO WALK THE PT THROUGH TROUBLESHOOTING BUT IT SEEMED THAT THE COMMUNICATOR WASN'T CHARGED. AGENT INSTRUCTED PT TO CHARGE THE COMMUNICATOR, THEN CALL BACK FOR FURTHER ASSISTANCE. PT SEEMED CONFUSED WITH HOW THE EXTERNAL EQUIPMENT WORKS. PT KEPT COMMENTING THAT THE COMMUNICATOR WAS CHARGED BUT WAS LOOKING AT THE CHANGE LEVEL OF THE HANDSET, NOT THE COMMUNICATOR. CALLER ALSO ADDED THAT THEY'VE BEEN SEEING ERI FOR A WHILE AND HAVE BEEN APPROVED TO HAVE THEIR INS REPLACED. PT SAID THEY HAVE AN UPCOMING APPOINTMENT ON (B)(6) 2026.

  Patient problems: Electric Shock

  MAUDE report 25780713 ↗
• MalfunctionJul 8, 2026Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT STATED THE STIMULATION HAD NOT HELPED THEIR BACK PAIN AT ALL SINCE IMPLANT. PATIENT SAID THEY HAD MET WITH THE MANUFACTURER REPRESENTATIVE (REP) ON SEVERAL OCCASIONS FOR REPROGRAMMING, BUT THEY COULDN'T GET STIM TO HELP THE LOWER RIGHT SIDE OF THEIR BACK. PATIENT SAID THEY HAD THEIR PROGRAMS TURNED OFF FOR A FEW MONTHS NOW, BUT OVER THE LAST 2-3 WEEKS, THEY HAD BEEN STARTING TO EXPERIENCE A LOW GRADE BUZZING OR VIBRATING IN THEIR LOWER RIGHT FRONT SIDE OF THEIR HIP, WHICH THEY THOUGHT WAS COMING SOMEHOW FROM THE STIMULATOR. PATIENT SAID THE BUZZING THEY WERE FEELING REMINDED THEM OF THE STIMULATION, BUT THEY DIDN'T KNOW HOW TO TURN IT OFF. THE DOCTOR TOLD PATIENT TO CALL ABOUT THE ISSUE. PATIENT SAID IMPLANT WAS IN THE LOWER LEFT FLANK, AND THE BACK PAIN THEY WERE TRYING TO ADDRESS AT THE BEGINNING WAS THE MID PART OF THEIR RIGHT SIDE OVER ON THEIR BACK APPROACHING THEIR HIP BONE. AGENT HAD PATIENT CONNECT TO THEIR APP AND PATIENT CONFIRMED THERAPY WAS ALREADY OFF. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRE

  Patient problems: Insufficient Information

  MAUDE report 25748273 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CONTACTED SUPPORT REGARDING AN IMPLANTABLE NEUROSTIMULATOR PAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT STATED THAT BEGINNING IN (B)(6) 2025 THE IMPLANTABLE NEUROSTIMULATOR STARTED CAUSING PAIN ¿24/7.¿ THE PATIENT REPORTED THAT THE RIGHT-SIDE IMPLANTABLE NEUROSTIMULATOR WAS REMOVED IN (B)(6) 2025 OR (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 25691030 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THEY WERE EXPERIENCING WHAT THEY UNDERSTAND IS A "PAIN POCKET". PATIENT CLARIFIED THEY WERE HAVING INTENSE PAIN UNDER AND AROUND THE IMPLANT SITE. PATIENT SAID THIS HAPPENED WITH THEIR LAST IMPLANT TOWARDS THE END (PATIENT SAID FOR THE LAST YEAR OF HAVING THAT IMPLANT). PATIENT SAID THEY NEVER KNEW WHAT CAUSED IT AND WAS GIVEN A LOT OF ANTIBIOTICS. PATIENT SAID THEY CAME HOME AND GOT THE SMALLER IMPLANT (THEIR CURRENT IMPLANT).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25665767 ↗
• InjuryJun 29, 2026Battery Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT REPORTED THAT THEIR INS BATTERY WAS DRAINING QUICKLY AND WOULD NOT LAST A DAY OR TWO. PATIENT NOTIFIED MANUFACTURING REPRESENTATIVE (REP) AT THE SAME TIME THEY'RE SEEING ERI. PATIENT WAS SEEN FOR REPROGRAMMING TO OPTIMIZE CHARGE FREQUENCY. AGENT DOCUMENTED INFORMATION GIVEN ON CALL. PATIENT MENTIONED HISTORICAL INFORMATION THAT WHEN THEY'RE TRYING TO CONNECT TO MYSTIM, IT WOULD SAID CONNECTING FOREVER. PATIENT REPORTED THEY KEEP RECEIVING SERVICE CODE 201 (ERI) PATIENT STATED THEY STARTED SEEING THE MESSAGE 6 MONTHS AGO. PATIENT ALREADY NOTIFIED REP AND THEY REVIEWED MEANING OF MESSAGE AND REPROGRAMMED PATIENT. AGENT CONTINUED TO REDIRECT PATIENT TO HCP AND REVIEWED ERI AGAIN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. WHEN ASKED ABOUT THE CAUSE, THEY REPORTED THAT ONCE IT WAS FIXED BY MEETING WITH THE MANUFACTURER REPRESENTATIVE (REP), THEY KEPT IT CONSTANTLY PLUGGED IN. THEY STATED THAT IT WAS TOO HARD TO START IT IF IT IS OFF A LITTLE TOO LONG. WHEN ASKED ABOUT THE STEPS TAKEN, THEY STATED THAT THEY PROBABLY WILL GET A NEW INTERNAL (SURGICAL) REPLACEMENT. WHEN ASKED AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661537 ↗
• MalfunctionJun 29, 2026Failure to Deliver Energy; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETURN OF PAIN WITH WALKING DIFFICULTY, IMMOBILITY, LOSS OF BALANCE, AND BEING UNABLE TO GET OUT OF BED. HIGH IMPEDANCE WAS IDENTIFIED ON IMPEDANCE ASSESSMENT/MEASUREMENT, AND IT WAS REPORTED THAT HALF OF THE LEAD WAS NOT ABLE TO BE USED. THE PATIENT WAS SEEN FOR REPROGRAMMING AND WAS REPROGRAMMED AROUND THE IMPEDANCES, WHICH ACHIEVED RIGHT-SIDED COVERAGE; LEFT-SIDED COVERAGE WAS NOT ACHIEVED DUE TO THE INABILITY TO USE HALF OF THE LEAD. THE ISSUE WAS REPORTED AS ONGOING AND NOT RESOLVED. THE PATIENT WAS TO TRY A NEW PROGRAM PER THE PHYSICIAN¿S REQUEST AND WAS PLANNED TO BE CONSULTED FOR REVISION OF THE STIMULATOR PER THE PHYSICIAN. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 25651764 ↗
• InjuryJun 24, 2026Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS THE CALLER REPORTED THAT THE PATIENT'S BATTERY IS ALREADY SHOWING END OF SERVICE AND IT HAS ONLY BEEN ABOUT A YEAR. THE CALLER STATED THAT THEY INTERROGATED THE INS AND, IN THE SESSION, THEY WERE NOT ABLE TO ACCESS ANY OF THE THERAPY PARAMETERS. THE CALLER STATED THAT IT WAS A POOR ENGINEERING DECISION NOT TO HAVE ACCESS TO THE PARAMETERS AFTER THE INS HAD REACHED EOS. THE CALLER ACCESSED THE REPORT FROM THE SESSION WITH THE SESSION WITH THE INS AND IT INCLUDED THE PROGRAMMED PARAMETERS. THE PATIENT HAD ONE GROUP WITH TWO PROGRAMS WITH ONE CATHODE AND ANODE - 3.3MA 450US 100HZ. TECHNICAL SERVICE ENTERED THE INFORMATION INTO THE ENERGY ESTIMATION TOOL ON THE TABLET WHICH ESTIMATED THE LONGEVITY WOULD BE 1 YEAR AND 1 MONTH. THE CALLER WILL REVIEW INFORMATION WITH THE MANAGING MD. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. WHEN ASKED TO CLARIFY IF THE PATIENT'S END OF SERVICE/EOS WAS NORMAL BASED ON SETTINGS AND USE THE REP REPORTS THE PT STATED THEY HAD THE SAME SETTINGS WITH A PREVIOUS IMPLANT AND IT HAD LASTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611714 ↗
• InjuryJun 8, 2026Migration or Expulsion of Device; Energy Output Problem

  THE PATIENT (PT) REPORTED NOT GETTING COVERAGE ON LEFT SIDE AND LOWER BACK/HIPS REGION. IMAGING SHOWED BOTH LEADS MIGRATED DOWN 2 VERTEBRAL BODIES, AND SHIFTED TO THE RIGHT. LEADS WERE REPLACED ON (B)(6) 2026 AND REPORTED THE LEADS WERE TO BE RETURNED TO MANUFACTURER. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Insufficient Information

  MAUDE report 25433239 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER REMOVED THEIR DEVICE BECAUSE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25394671 ↗
• MalfunctionJun 4, 2026Therapy Delivered to Incorrect Body Area; Data Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THAT WHEN THERAPY WAS TURNED ON, ALL GROUPS WERE ON, AND WHEN ONLY ONE GROUP WAS TURNED OFF, ALL GROUPS WENT OFF. AGENT REVIEWED INFORMATION. PATIENT STATED THEY HAD THREE GROUPS A, B, AND C TARGETING DIFFERENT AREAS, AND ALTHOUGH THEY ONLY NEEDED ONE GROUP FOR DESIRED STIMULATION, THEY COULD NOT TURN OFF OTHER GROUPS, RESULTING IN STIMULATION ACROSS MORE PARTS OF BODY. AGENT REDIRECTED PATIENT TO HCP AND MDT REP FOR FURTHER ASSISTANCE.

  Patient problems: Insufficient Information

  MAUDE report 25393104 ↗
• MalfunctionMay 22, 2026Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT SAID THEY HADN'T USED THE COMMUNICATOR IN MAYBE 5-4 YEARS, BUT THEY THOUGHT THEY WOULD TRY IT AGAIN. PATIENT WENT TO SEE THE MEDTRONIC REPRESENTATIVE AT THE HOSPITAL A COUPLE DAYS AGO AND THE REPRESENTATIVE COULDN'T GET THE TM91 TO TURN ON. PATIENT SAID THE REPRESENTATIVE SAID THE IMPLANT WAS AT 60% BUT THE COMMUNICATORS WOULDN'T TURN ON AT ALL. PATIENT ALSO SAID THE INTENSITY WAS A LITTLE TOO MUCH FOR HIM RIGHT NOW, HIS LEGS AND FEET WERE PRACTICALLY NUMB AND IT WAS HARD TO WALK. PATIENT MENTIONED THAT THEY WALK LIKE THEY ARE HALF DRUNK WHEN THEY GET OFF BALANCE. DURING THE CALL, THE COMMUNICATOR WOULDN'T POWER ON. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT. PATIENT WAS REDIRECTED TO HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Ambulation or Postural Difficulties; Numbness

  MAUDE report 25255609 ↗
• MalfunctionMay 15, 2026Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE CALLER REPORTED THAT THE PATIENT NEEDS TO GET AN MRI AND THE PATIENT SAID THAT THE DEVICE IS NOT WORKING. THE CALLER DID NOT HAVE ANY OTHER DETAILS ABOUT THE DEVICE NOT WORKING BUT SAID THAT IT DOES NOT ZAP THE PATIENT ANY MORE. THE CALLER WANTED TO KNOW IF THERE WAS A WAY TO FIND OUT IF THE DEVICE WASN'T WORKING BECAUSE THE BATTERY WAS DEAD OR IF THERE WERE SOME OTHER KIND OF PROBLEM WITH THE DEVICE. AGENT REVIEWED DEVICE INFORMATION WITH THE CALLER. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER WILL FOLLOW-UP WITH THE PHYSICIAN.

  Patient problems: Insufficient Information

  MAUDE report 25186602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis