Activa® 37612Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,325 adverse event reports that list this exact device (DI 00613994934611), received between Apr 16, 2015 and Sep 23, 2026 — classified as 205 injuries, 1,120 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (381 reports).

20 other recalls cover devices cleared under the same FDA submission (P960009); 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 1,325 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Data Problem

  Patient problems: Insufficient Information

  MAUDE report 50876327 ↗
• MalfunctionSep 23, 2026Delayed Charge Time; Charging Problem

  It was reported that the patient recently started using their DBS again and they said they need to charge it more frequently and for longer periods. Patient said they are very petite, and the charging harness that originally came with their DBS was much too large for and was basically unusable. Currently, the patient's representative helps the patient place the charger inside their shirt and wrap a post-surgical compression band around their chest to help hold it in the correct position. Patient states they also have athetoid cerebral palsy, so involuntary movement makes it especially important that the charger stay securely positioned while they charge. Patient was inquiring about a smaller charging harness, or another accessory compatible with their older rechargeable DBS system that would hold the charger securely in place on a very petite person.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872536 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported that the patient underwent explant of the prior complete DBS system in order to improve outcomes and to make the patient MRI compatible. The patient¿s disease had progressed and the patient was reported to be unilateral only at the time of the event. The surgeon completed bilateral surgery to achieve the best possible outcomes. The issue was considered resolved at the time of the report, and no additional information was available from the healthcare professional.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304852 ↗
• MalfunctionAug 6, 2026Failure to Deliver Energy; Charging Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153556 ↗
• MalfunctionJul 31, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097922 ↗
• MalfunctionJul 15, 2026High impedance; Delayed Charge Time

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25827325 ↗
• MalfunctionJul 10, 2026Failure to Deliver Energy

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 25781094 ↗
• MalfunctionJun 15, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN EXTERNAL DEVICE. THE PATIENT'S REPORTED THE PATIENT HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. UPON FURTHER CONSIDERATION, REOPENED CASE TO SEND REPAIR REQUEST FOR A 37761 AND THEN CLOSED CASE AGAIN. REPAIR TASK (B)(4) WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498824 ↗
• MalfunctionJun 4, 2026Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT FOR THE PAST FEW MONTHS THE PATIENT NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES DIDN'T SEEM TO HOLD A CHARGE AS LONG. THE PATIENT'S MANAGING HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE INS BATTERIES MIGHT NOT BE HOLDING A CHARGE AS LONG BECAUSE THEY WILL BE DUE FOR REPLACEMENT BY THE END OF THE YEAR. THE PATIENT ALSO NOTICED THAT THE WIRELESS RECHARGER (WR) SEEMED TO HAVE MORE DIFFICULTY FINDING THE INS BATTERIES AND MAINTAINING A CONNECTION WITH THEM. THE CALLER LIVED OUT OF STATE SO THEY WERE UNABLE TO TROUBLESHOOT, BUT THEY SAID THEY WOULD HAVE THE PATIENT'S FRIEND CALL BACK WHEN THEY ARE WITH THE PATIENT TO TROUBLESHOOT THE COUPLING ISSUE. PATIENT REP CALLED REGARDING THE SAME ISSUE AND MENTIONED PREVIOUSLY REPORTED INFORMATION. CALLER ADDED THAT THEY MAKE SURE THAT THE BULLSEYE ON THE WR WAS ALIGNED WITH THE PATIENT'S IMPLANT WHEN THEY CHARGED, AND THAT THE FLOORING IN THE PATIENT'S BEDROOM WAS MAGNETIZED. DURING THE CALL, AGENT REVIEWED GENERAL DEVICE USE, EMI/MAGNETS COMPATIBILITY INFORMATION AND THERAPY INFORMATION, THEN WALKED CALLER THROUGH CONNECTING TO THE PATIENT'S IMPLANT TO CHECK THE IMPLANT'S BATTERY. CALLER CONFIRMED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399923 ↗
• MalfunctionJun 4, 2026Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT FOR THE PAST FEW MONTHS THE PATIENT NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES DIDN'T SEEM TO HOLD A CHARGE AS LONG. THE PATIENT'S MANAGING HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE INS BATTERIES MIGHT NOT BE HOLDING A CHARGE AS LONG BECAUSE THEY WILL BE DUE FOR REPLACEMENT BY THE END OF THE YEAR. THE PATIENT ALSO NOTICED THAT THE WIRELESS RECHARGER (WR) SEEMED TO HAVE MORE DIFFICULTY FINDING THE INS BATTERIES AND MAINTAINING A CONNECTION WITH THEM. THE CALLER LIVED OUT OF STATE SO THEY WERE UNABLE TO TROUBLESHOOT, BUT THEY SAID THEY WOULD HAVE THE PATIENT'S FRIEND CALL BACK WHEN THEY ARE WITH THE PATIENT TO TROUBLESHOOT THE COUPLING ISSUE. PATIENT REP CALLED REGARDING THE SAME ISSUE AND MENTIONED PREVIOUSLY REPORTED INFORMATION. CALLER ADDED THAT THEY MAKE SURE THAT THE BULLSEYE ON THE WR WAS ALIGNED WITH THE PATIENT'S IMPLANT WHEN THEY CHARGED, AND THAT THE FLOORING IN THE PATIENT'S BEDROOM WAS MAGNETIZED. DURING THE CALL, AGENT REVIEWED GENERAL DEVICE USE, EMI/MAGNETS COMPATIBILITY INFORMATION AND THERAPY INFORMATION, THEN WALKED CALLER THROUGH CONNECTING TO THE PATIENT'S IMPLANT TO CHECK THE IMPLANT'S BATTERY. CALLER CONFIRMED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399918 ↗
• MalfunctionMay 20, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DTC CORD'S METAL TIP HAD BROKEN OFF, AND IS NEEDING REPLACEMENT. AGENT REQUESTED A REPLACEMENT DTC CORD THROUGH REPAIR, AND REVIEWED REPLACEMENT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225787 ↗
• MalfunctionMay 1, 2026Charging Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (PT) HAS BEEN HAVING SOME PROBLEMS WITH THEIR BACK. THE CALLER REPORTED THAT THE DBS DEVICES ARE NOT WORKING AND THEY WANT TO KNOW IF THAT IS CAUSING THE BACK PROBLEMS. THE CHIROPRACTOR THINKS THERE IS A CHANCE THAT THE BRAIN CONTROLS THE MOVEMENTS AND BALANCE AND THAT MAYBE THAT COULD BE AFFECTING THE BACK. THE CALLER NOTED THAT THEIR BODY LEANS WAY TO THE LEFT AND THEY ARE WONDERING IF THAT IS CAUSING THE ISSUES THEY ARE HAVING IN THEIR BACK." THE CALLER ALSO NOTED THAT THEY HAD HEART SURGERY ABOUT 2 YEARS AGO AND AFTER THE HEART SURGERY, THEY NOTICED THAT THEY WERE HAVING A HARD TIME GETTING THE GENERATORS CHARGED, SO THEY WERE ONLY CHARGING THEM UP PARTIALLY. AGENT ASKED THE CALLER IF THEY ARE CHARGED AND ON. THE CALLER REPORTED THAT ONE SIDE WAS RECENTLY CHARGED TO 100% BUT THEY ARE NOT SURE IF IT IS ON BECAUSE THEY DO NOT KNOW HOW TO DO THAT. AGENT EXPLAINED THAT IF THEY WERE ALLOWED TO DISCHARGE, THERAPY WOULD BE OFF AND IT WOULD HAVE TO MANUALLY TURN BACK ON AGAIN. THE CALLER WILL CHARGE UP THE DEVICES AND CALL FOR HELP CONFIRMING OR TURNING THEM ON. THE CALLER SEES THE HEALTHCARE PROVIDER (HCP) ON APRIL 27TH AND THEY WILL DISCUSS REPLACEMENTS.

  Patient problems: Insufficient Information

  MAUDE report 25060172 ↗
• MalfunctionMay 1, 2026Charging Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (PT) HAS BEEN HAVING SOME PROBLEMS WITH THEIR BACK. THE CALLER REPORTED THAT THE DBS DEVICES ARE NOT WORKING AND THEY WANT TO KNOW IF THAT IS CAUSING THE BACK PROBLEMS. THE CHIROPRACTOR THINKS THERE IS A CHANCE THAT THE BRAIN CONTROLS THE MOVEMENTS AND BALANCE AND THAT MAYBE THAT COULD BE AFFECTING THE BACK. THE CALLER NOTED THAT THEIR BODY LEANS WAY TO THE LEFT AND THEY ARE WONDERING IF THAT IS CAUSING THE ISSUES THEY ARE HAVING IN THEIR BACK." THE CALLER ALSO NOTED THAT THEY HAD HEART SURGERY ABOUT 2 YEARS AGO AND AFTER THE HEART SURGERY, THEY NOTICED THAT THEY WERE HAVING A HARD TIME GETTING THE GENERATORS CHARGED, SO THEY WERE ONLY CHARGING THEM UP PARTIALLY. AGENT ASKED THE CALLER IF THEY ARE CHARGED AND ON. THE CALLER REPORTED THAT ONE SIDE WAS RECENTLY CHARGED TO 100% BUT THEY ARE NOT SURE IF IT IS ON BECAUSE THEY DO NOT KNOW HOW TO DO THAT. AGENT EXPLAINED THAT IF THEY WERE ALLOWED TO DISCHARGE, THERAPY WOULD BE OFF AND IT WOULD HAVE TO MANUALLY TURN BACK ON AGAIN. THE CALLER WILL CHARGE UP THE DEVICES AND CALL FOR HELP CONFIRMING OR TURNING THEM ON. THE CALLER SEES THE HEALTHCARE PROVIDER (HCP) ON APRIL 27TH AND THEY WILL DISCUSS REPLACEMENTS.

  Patient problems: Insufficient Information

  MAUDE report 25060141 ↗
• MalfunctionApr 28, 2026Delayed Charge Time

  IT WAS REPORTED THAT PATIENT WAS HAVING A HARD TIME WALKING AGAIN. CALLER SAID THE PATIENT HAD BEEN CHARGING THE IMPLANT EVERY OTHER OR EVERY DAY AND IT WAS TAKING FOREVER TO CHARGE THE IMPLANT. AGENT ASKED, CALLER SAID THE ISSUE HAD BEEN GOING ON FOR A WHILE AND THAT IT HAD BEEN TAKING 6-7 HOURS TO CHARGE. CALLER CONFIRMED THERE WAS NO DAMAGE TO THE RECHARGER. CALLER MENTIONED THAT THEY HAD THE RECHARGING CABLE REPLACED NOT TOO LONG AGO BECAUSE IT WAS BENDING. DURING THE CALL, CALLER WAS ABLE TO START A CHARGING SESSION WITH ALL 8 COUPLING BOXES FILLED IN. AGENT REVIEWED RECHARGING EXPECTATIONS WITH THE CALLER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.".

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25020824 ↗
• MalfunctionApr 28, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE RECHARGER CORD WAS FRAYED. A REPLACEMENT WAS SENT. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT REP CALLED BACK STATING CALLING PREVIOUSLY TO HAVE DESKTOP CHARGER REPLACED AND NOTICED RIGHT WHEN THEY GOT IT THE PIN ON THE END WAS LOOSE. YESTERDAY IT FELL APART WHEN PLUGGING IN. AGENT SENT REQUEST TO REPAIR. THE PATIENT REP CALLED BACK AND REPEATED INFORMATION REGARDING THE BROKEN DTC CONNECTOR PIN REPORTED IN THE FOLLOW UP NOTE FROM 20-APR-2026. THE CALLER WAS EXPECTING THE REPLACEMENT DTC TO BE DELIVERED YESTERDAY, BUT PER FEDEX IT WAS DELIVERED TO THE WRONG ADDRESS. THE CALLER WAS GETTING WORRIED BECAUSE THE PATIENT'S INS BATTERY LEVEL WAS GETTING LOW, AND THEY SAID THE PATIENT COULD END UP IN THE HOSPITAL IF THE THERAPY TURNS OFF. THE CALLER SAID THEY SPOKE WITH MANUFACTURING REP TODAY TO EXPRESS THEIR CONCERN, AND THE REP ADVISED THE CALLER TO CALL PATIENT SERVICES TO SEE IF A REQUEST FOR ANOTHER DTC COULD BE MADE FOR OVERNIGHT DELIVERY. AGENT CHECKED FEDEX TRACKING, WHICH ALIGNED WITH WHAT FEDEX TOLD THE CALLER. AGENT REVIEWED THAT ANOTHER REPAIR REQUEST COULD NOT BE SUBMITTED SINCE THE PACKAGE IS SHOWING AS READY FOR DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012487 ↗
• MalfunctionApr 28, 2026Failure to Deliver Energy; No Device Output; Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT ABOUT 3-4 DAYS AGO THE PATIENT STARTED SHAKING REALLY BAD, AND THE SHAKING HAS GOTTEN WORSE. THE CALLER WAS UNDER THE IMPRESSION THAT THE THERAPY HAD TURNED OFF, BUT THEY WERE UNABLE TO TURN THE THERAPY BACK ON BECAUSE THEY WERE SEEING A SCREEN ON THE PATIENT PROGRAMMER THAT DIDN'T MAKE SENSE TO THEM. THE CALLER CALLED MANUFACTURER REP, AND THE REP TOLD THE CALLER THAT THEY WOULD TRY TO GET AHOLD OF SOMEONE TO GET AN APPOINTMENT FOR A REPLACEMENT IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THE REP WAS UNDER THE IMPRESSION THE INS BATTERY MIGHT BE OVER DISCHARGED. THE CALLER WAS CONCERNED ABOUT THE PATIENT'S SHAKING AND THEY NEEDED TO TURN THE THERAPY BACK ON IMMEDIATELY. THE CALLER INITIALLY GOT THE 'POOR COMMUNICATION' SCREEN WHEN THEY TRIED CONNECTING TO THE INS. THE CALLER REPOSITIONED THE PROGRAMMER BUT STILL COULD NOT CONNECT TO THE INS. THE CALLER REPLACED THE AAA BATTERIES IN THE PROGRAMMER, THEN THEY SAW THE 'REPLACE PATIENT PROGRAMMER BATTERIES' WARNING SCREEN. THE CALLER NOTICED BROWN DUST IN THE BATTERY COMPARTMENT AS THEY WERE REPLACING THE BATTERIES OF THE PROGRAMMER. THE CALLER INSERTED BRAND-NEW AAA BATTERIES, BUT THEY CONTINUED TO GET THE 'POOR CO

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

  MAUDE report 25011952 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEONS OFFICE STATED COMPLETE SYSTEM EXPLANT DUE TO EROSION OF IMPLANT. CAUSE AND DATE UNKNOWN BY OFFICE.

  Patient problems: Erosion

  MAUDE report 24925636 ↗
• MalfunctionApr 17, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT¿S REPRESENTATIVE STATED THAT SEVERAL DAYS EARLIER, THE PATIENT HAD LET THE DEVICE DEPLETE COMPLETELY. THEY ADDED THAT THEY USED TO CHARGE EVERY THREE DAYS, BUT SINCE THE DEPLETION EVENT, IT NOW REQUIRES CHARGING MULTIPLE TIMES PER DAY. THE BATTERY REPORTEDLY DROPS BY ABOUT 50% SHORTLY AFTER 2 HOURS OF CHARGING, THE THERAPY GOES OFF, AND THE PATIENT EXPERIENCES SHAKING AND KICKING MOVEMENTS WHEN THIS OCCURS. THE REPRESENTATIVE STATED THAT THE PATIENT HAD RECENTLY BEEN SEEN AT A CLINIC FOR MEDICATION ADJUSTMENTS. THEY WISH THEY HAD NEVER LET THEM GO BECAUSE THEY CAME HOME 'LIKE A VEGETABLE'. INFORMATION WAS REVIEWED, EXPLAINING THAT ALLOWING THE BATTERY TO DEPLETE FULLY WOULD DAMAGE IT. THE BATTERY WILL DEPLETE FASTER. THEY WILL NEED TO CHARGE THE BATTERY TO 100% THE NEXT 3-6 TIMES TO BUILD THE BATTERY BACK UP. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO ADDRESS THE ISSUE FURTHER.

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 24916512 ↗
• MalfunctionApr 8, 2026Intermittent Continuity; Failure to Deliver Energy

  IT WAS REPORTED THAT PATIENT FELT LIKE THE IMPLANT BATTERY WAS TURNING OFF AND ON. CALLER SAID THE PATIENT JUST MOVED INTO A NEW APARTMENT AND THE PATIENT DIDN'T KNOW IF IT WAS SOMETHING IN THE APARTMENT THAT WAS MAKING THE BATTERY SHUT OFF. CALLER ASKED IF THERE WAS ANY THAT COULD TELL THAT THE BATTERY WAS SHUTTING OFF AND ON BECAUSE THE PATIENT SAID IT WAS GOING IN WAVES LIKE IT WOULD CUT BACK ON AND OFF. AGENT ASKED IF CALLER HAD THE PATIENT'S DEVICE TO CHECK THE IMPLANT AND CALLER SAID THE IMPLANT WAS ON, BUT THE PATIENT WAS STILL FEELING LIKE THE DEVICE WAS CUTTING ITSELF OFF. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24816503 ↗
• MalfunctionApr 7, 2026Delayed Charge Time

  IT WAS REPORTED THAT PATIENT WONDERING HOW LONG THEY SHOULD WAIT BEFORE TALKING TO HEALTHCARE PROVIDER ABOUT REPLACING THE BATTERY. PATIENT STATES IT HAS BEEN TAKING LONGER TO CHARGE FOR ABOUT A YEAR. AGENT ASKED IF PATIENT CHARGES ALL THE WAY FULL WHEN THEY CHARGE AND PATIENT STATES YES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT HAS AN APPOINTMENT WITH HEALTHCARE PROVIDER AROUND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810382 ↗
• MalfunctionMar 30, 2026Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE PATIENT'S REPORTED THAT FOR ABOUT THE PAST 5 DAYS, THE PATIENT'S PARKINSON'S SYMPTOMS HAD STARTED TO COME BACK BECAUSE THE WALL ADAPTOR FOR THE WIRELESS RECHARGER DOCK HAD BEEN LOST AND THEY WERE CURRENTLY UNABLE TO CHARGE THE WIRELESS RECHARGER. CALLER SAID THEY WERE TRYING TO CONSERVE THE BATTERY OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SO THEY HAD IT TURNED OFF FOR NOW AND AS A RESULT, THE PATIENT WAS FLOPPING AROUND WITH THEIR LIMBS AND LEGS. CALLER STATED THEY NEEDED TO CHARGE THE WIRELESS RECHARGER SO THEY COULD CHARGE THE IMPLANTED NEUROSTIMULATOR SO THE PATIENT WAS ABLE TO BE "CALMER" WITH THE THERAPY BACK ON. WITH THE THERAPY BACK ON, THE CALLER EXPLAINED THAT THE PATIENT COULD EAT AND WRITE ON THEIR OWN AGAIN BUT THEY HADN'T BEEN ABLE TO BECAUSE THEY LOST ADAPTOR. CALLER INITIALLY DESCRIBED THE DOCK WALL ADAPTOR AS BLACK BUT IT WAS FURTHER CONFIRMED THE TYPE OF RECHARGING SYSTEM THEY HAD. PATIENT SERVICES REVIEWED WITH THE CALLER THAT THEY SHOULD HAVE A THICK WHITE CABLE THAT PLUGS INTO THE BACK OF THE DOCK AND CALLER DID CONFIRM THEY H AD THE CABLE

  Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726023 ↗
• InjuryMar 30, 2026Battery Problem

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE ISSUE OF THE INS NOT HOLDING A CHARGE WELL WAS A TTRIBUTED TO NORMAL BATTERY DEPLETION AND WAS FIRST OBSERVED IN (B)(6) 2026. THE CUSTOMER WAS NOT ASKED TO RETURN THE DEVICE; IT HAS NOT BEEN RETURNED FOR ANALYSIS; IT REMAINS IN THE PATIENT¿S POSSESSION. THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718913 ↗
• MalfunctionMar 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SAID THEIR DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR (INS) WASN'T WORKING A HUNDRED PERCENT, WAS NOT CURRENTLY NOT WORKING PROPERLY. THE PATIENT¿S RIGHT ARM WAS HAVING A LITTLE TROUBLE AND WAS SHAKING.

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 24646155 ↗
• MalfunctionMar 19, 2026Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

  THE PATIENT PROVIDED ADDITIONAL INFORMATION INDICATING THAT THEY ARE UNSURE IF THE ISSUE WAS RESOLVED.

  Patient problems: Electric Shock; Neck Pain; Pain; Partial Hearing Loss

  MAUDE report 24641437 ↗
• MalfunctionMar 17, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT IN THE PAST IF THE HEALTHCARE PROVIDER (HCP) INCREASED THEIR STIMULATION THEY WOULD USUALLY FEEL "A JOLT" WHEN THEY DID IT BUT THE PATIENT WASN'T FEELING ANYTHING. PATIENT SERVICES DID NOT ASK ANY FURTHER QUESTIONS REGARDING THIS COMMENT AS THE PATIENT WAS REPORTING MEDICAL HISTORY AND PATIENT SERVICES WAS FOCUSED ON THE REASON FOR CALL. PATIENT SERVICES REVIEWED THERAPY EXPECTATIONS AND PROGRAMMING CONSIDERATIONS WITH THE PATIENT AND REDIRECTED THE PATIENT TO FOLLOW UP WITH THEIR MANAGING HEALTH CARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock

  MAUDE report 24622307 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• 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-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.