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Percept™ PC BrainSense™ B35200 (UDI 00763000519216)Recalls & reported problems

Medtronic, Inc. · INS B35200 DBS PERCEPT PC EMANUAL EN · Class 3 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Medtronic Percept PC brain stimulator is an implanted device. Its 479 adverse event reports often describe high resistance readings in the leads, failed programmer connections, and battery problems. There are no deaths and 216 injuries. Reports fell from 66 in the prior 12 months to 35 in the last 12. There is 1 open recall, started in March 2022, where the implanted stimulator cannot communicate with the clinical or patient programmer.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
478
Deaths reported
0
Injuries reported
217
Recalls naming it
1

Summary

The FDA's MAUDE database contains 478 adverse event reports that list this exact device (DI 00763000519216), received between Feb 28, 2022 and Sep 30, 2026 — classified as 217 injuries, 261 malfunctions.

The most frequently reported specific device problem is “High impedance” (117 reports).

1 FDA recall record name this device's identifier, 1 still open.

19 other recalls cover devices cleared under the same FDA submission (H020007, H050003, 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.

Reports received per month

Nov 2023: 16 reportsDec 2023: 9 reportsJan 2024: 9 reportsFeb 2024: 12 reportsMar 2024: 13 reportsApr 2024: 4 reportsMay 2024: 4 reportsJun 2024: 11 reportsJul 2024: 14 reportsAug 2024: 4 reportsSep 2024: 9 reportsOct 2024: 5 reportsNov 2024: 1 reportsDec 2024: 4 reportsJan 2025: 8 reportsFeb 2025: 5 reportsMar 2025: 8 reportsApr 2025: 2 reportsMay 2025: 7 reportsJun 2025: 7 reportsJul 2025: 11 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 8 reportsNov 2025: 6 reportsDec 2025: 2 reportsJan 2026: 5 reportsFeb 2026: 0 reportsMar 2026: 8 reportsApr 2026: 5 reportsMay 2026: 2 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 5 reportsOct 2026: 0 reports20242025202616
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Mar 30, 2022Open, Classified

    The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

    Z-1128-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • High impedance117
  • Adverse Event Without Identified Device or Use Problem111
  • Insufficient Device Problem Information73
  • Battery Problem36
  • Communication or Transmission Problem32
  • Failure to Interrogate32
  • Impedance Problem32
  • Electromagnetic Compatibility Problem30

Patient problems

  • No Clinical Signs, Symptoms or Conditions253
  • Unspecified Infection55
  • Insufficient Information47
  • Shaking/Tremors44
  • Electric Shock21
  • Pain18
  • Discomfort17
  • Convulsion/Seizure15

Recent adverse event reports

The 25 most recent of 478 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Break; High impedance

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50947910 ↗
  • InjurySep 30, 2026Environmental Compatibility Problem; Insufficient Device Problem Information

    Patient problems: Discomfort; Insufficient Information; Scar Tissue; Shaking/Tremors

    MAUDE report 50946590 ↗
  • InjurySep 28, 2026Insufficient Device Problem Information

    Patient problems: Ambulation or Postural Difficulties; Dyskinesia; Fall; Shaking/Tremors

    MAUDE report 50923051 ↗
  • MalfunctionSep 25, 2026High impedance

    It was reported that 2C high impedance detected during programming session. This is not an activated electrode for therapy. No known external factors contributing to this. No further action planned at this time.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50897704 ↗
  • MalfunctionSep 10, 2026Failure to Interrogate; Communication or Transmission Problem

    Additional Info received from patient that they were able to get the handset and communicator to communicate to the patient's implant today by having the patient laying down. The engineering team has requested the rep to provide a summary of actions taken to better understand what troubleshooting steps were taken today and what they observed related to the position of the implant in the pocket given the large amount of weight gained then lost. It was reported that patient had a 60 lb weight gain with a 40 lb weight loss since getting DBS therapy. TS waiting for further information from the rep.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50715833 ↗
  • MalfunctionJun 1, 2026Display or Visual Feedback Problem; Energy Output Problem; Impedance Problem

    IT WAS REPORTED THAT PATIENT STATES TRYING TO CHANGE THERAPY. PATIENT IS IN GROUP B AND THE RIGHT HAS AN UP AND DOWN ARROW BUT THE LEFT DOES NOT. PATIENT STATES THEY WANT TO GO UP A TENTH BUT IT SAYS REVERT TO GROUP B. AGENT REVIEWED IT SEEMS PATIENT ONLY HAS ACCESS TO CHANGE THE RIGHT SIDE. PATIENT STATES CHANGING TO GROUP C BUT WAS SHAKING SO WENT BACK TO GROUP B. AGENT REDIRECTED TO HCP. PATIENT STATES DOCTOR WILL BE OUT UNTIL ON (B)(6) AND THEY WILL CALL TO SEE IF THERE IS ANOTHER DOCTOR THAT CAN HELP. PATIENT STATES FINDING OUT THERE IS AN IMPEDANCE ISSUE ON ONE OF THE GROUPS. PATIENT STATES BEING TOLD THEY WOULD NEED TO HAVE SURGERY TO RESOLVE THE ISSUE WITH THE IMPEDANCE BUT PATIENT STATES THERE IS A RISK OF A STROKE. PATIENT STATES THEY WERE TOLD THEY DID NOT HAVE TO USE THE GROUP WITH THE IMPEDANCE ISSUE. PATIENT DOES NOT KNOW WHAT GROUP THAT IS. PATIENT MENTIONED HAVING LEADS IMPLANTED FOR THE OTHER S IDE OF THE BRAIN ON (B)(6) 2024. SEE 609101609 FOR EKG INTERFERENCE.

    Patient problems: Shaking/Tremors

    MAUDE report 25350441 ↗
  • MalfunctionMay 22, 2026High impedance

    IT WAS REPORTED THAT INVESTIGATE IMPEDANCES WERE SHOWN ON CONTACT 8, 9CAND 10C. IMPEDANCES RUN AT 1 MA WITH NO CHANGE. NO TROUBLESHOOTING WAS PERFORMED AS PATIENT IS NOT PROGRAMMED ON THOSE CONTACTS. THE ISSUE IS NOT RESOLVED AT THE TIME OF REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25260724 ↗
  • InjuryMay 22, 2026Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE REVISIONS WITH THE DEVICE. WHEN ASKED FOR MORE DETAILS THE CALLER SAID THE PATIENT HAD SOMETHING CHANGED WITH THE ELECTRODES, AND THEN PROCEEDED TO READ A LIST OF COMPONENT EXPLANTS WHICH IS IN REGISTRATION. THE CALLER DID NOT KNOW THE REASONS FOR THE REVISIONS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25259620 ↗
  • InjuryApr 21, 2026Display or Visual Feedback Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

    IT WAS REPORTED THAT PATIENT WAS SEEN BY HEALTHCARE PROVIDER (HCP) TODAY, ON THE CLINICIAN PROGRAMMER, IT SHOWS 22% REMAINING ON IMP LANTABLE NEUROSTIMULATOR (INS) LONGEVITY. CALLER REPORTS THE PATIENT PROGRAMMER SHOWS 4 BATTERY BARS REMAINING. CALLER REPORTS PATIENT DID NOT SEE ERI MESSAGE. REVIEWED LONGEVITY CALLER REPORTED PATIENT IS EXPERIENCING INTERMITTENT SHOCKS/ VIBRATIONS UNDERNEATH THE DBS DEVICE FOR THE PAST 5 DAYS LASTING JUST A FEW SECONDS. CALLER STATED PATIENT HAS NOT CHANGED DBS SETTINGS AND IS NOT PROGRAMMED WITH ADAPTIVE STIM AND IS ONLY ON CONSTANT DBS. CALLER ALSO STATED THERE IS NO TRAUMA, NORMAL IMPEDANCE. CALLER IS NOT WITH THE PATIENT. CALLER REPORTS PATIENT IS SCHEDULED FOR INS REPLACEMENT TO RECHARGEABLE INS, CURRENTLY NO DATE REVIEWED LOG FILES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION RECEIVED FROM A REP INDICATING THAT SURGERY WAS INITIALLY PLANNED FOR NORMAL BATTERY DEPLETION AND IS ALSO HOW THEY WILL ADDRESS THE INTERMITTENT SHOCK ISSUE. NO DATE FOR SURGERY HAS BEEN CONFIRMED. REP REPORTED THE CAUSE OF THE INS SHOWING 22% AND 4 BARS IS NORMAL AND NOT AN ACTUAL ISSUE SO NO ACTIONS WERE

    Patient problems: Discomfort; Electric Shock

    MAUDE report 24946429 ↗
  • MalfunctionApr 21, 2026Electromagnetic Compatibility Problem

    IT WAS REPORTED THAT PATIENT HAD A PACEMAKER PUT IN YESTERDAY AND THEY GOT THE PACEMAKER PROGRAMMED APPROPRIATELY WHILE DBS WAS SHUT OFF. WHEN DBS WAS TURNED BACK ON THIS CAUSED ISSUES WITH THE SIGNAL AND SYNCHRONY OF THE PACEMAKER. .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24941809 ↗
  • InjuryApr 13, 2026Premature Discharge of Battery; High impedance; Positioning Problem

    ADDITIONAL INFORMATION RECEIVED FROM REP REPEATING PREVIOUSLY REPORTED PREMATURE DEPLETION IMPEDANCE, DEVICE REMOVAL, AND TANGLED WIRES. PATIENT ATTESTS TO HAVING SEVERAL RECENT FALLS BUT DENIES TWIDDLER'S SYNDROME. NEW BATTERY WAS IMPLANTED AND CLEARED IMPEDANCE TESTS.

    Patient problems: Fall; Twiddlers Syndrome

    MAUDE report 24854101 ↗
  • InjuryApr 8, 2026Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION TO PLACE AN IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2026. THE CALLER STATED THAT THEY DID NOT KNOW THE REASON FOR THE REVISION. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES REVIEWED REGISTRATION INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24818890 ↗
  • MalfunctionApr 6, 2026Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem

    IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE COMMUNICATOR. THE REASON FOR CALL WAS PATIENT REPORTED THAT LAST TUESDAY THEY WOKE UP IN THE HOSPITAL AFTER HAVING SEIZURES AND THEY HIT THEIR HEAD A COUPLE TIMES. PATIENT SAID THEY CALLED THEIR NEUROLOGIST FACILITY ON THURSDAY AND THE NURSE THAT THEY SPOKE WITH MENTIONED THE POSSIBILITY OF THE DEEP BRAIN (DBS) STIMULATOR TURNING OFF FROM THE PATIENT HITTING THEIR HEAD. PATIENT ASKED IF DBS COULD TURN OFF FROM HITTING THEIR HEAD. PATIENT SERVICES AGENT REVIEWED INFORMATION ABOUT IMPLANTED NEUROSTIMULATOR AND BATTERY LONGEVITY AND REDIRECTED PATIENT TO HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT MENTIONED THAT THEY JUST SPOKE WITH A MANUFACTURING REPRESENTATIVE, TODAY BECAUSE SINCE LAST TUESDAY THEY NOTICED THEIR COMMUNICATOR WOULD NOT PAIR WITH THEIR DBS THERAPY APPLICATION. PATIENT SAID THE COMMUNICATOR ONLY POWERED ON WHEN IT WAS PLUGGED INTO THE CHARGING CABLE BUT WHEN THE COMMUNICATOR WAS UNPLUGGED FROM THE CHARGING CABLE THE COMMUNICATOR WAS NON RESPONSIVE. HARD RESET AND TROUBLESHOOTING WITH THE MEDTRONIC REPRESENTATIVE DID NOT RESOLVE THE ISSUE. THE ISSUE WAS NOT RESOLVED.

    Patient problems: Convulsion/Seizure

    MAUDE report 24788546 ↗
  • InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

    DEVICE INFORMATION WAS PROVIDED.

    Patient problems: Bone Fracture(s); Fall

    MAUDE report 24745299 ↗
  • MalfunctionMar 30, 2026High impedance

    IT WAS REPORTED THAT THEY EVALUATED THE PATIENT'S DBS YESTERDAY AND IT WAS SHOWING THAT SOME OF THE LEADS HAD HIGH IMPEDANCE VALUES. CALLER STATED THEY WANTED TO SEE IF IT WOULD BE SAFE TO DO AN MRI BRAIN TO FURTHER EVALUATE FOR THE CHANGE IN PATIENT'S SYMPTOMS. AGENT REVIEWED MRI GUIDELINES WITH THE CALLER. WHEN ASKED FOR THE EVENT DATE, CALLER STATED THAT IT WAS PRIOR TO YESTERDAY. CALLER ALSO STATED THAT THE PATIENT WAS FOUND DOWN AT A NURSING CENTER WITH ALTERED MENTAL STATUS AND RIGIDITY AND IS NOW BEING EVALUATED BY AN ON-CALL NEUROSURGEON.

    Patient problems: Cognitive Changes; Muscular Rigidity

    MAUDE report 24719285 ↗
  • MalfunctionMar 26, 2026Failure to Deliver Energy; Battery Problem

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE CAUSE OF THE THERAPY BEING OFF DUE TO USER ERROR. PATIENT INADVERTENTLY TURNED IT OFF. DEVICE EDUCATION WAS PROVIDED TO RESOLVE THE ISSUE. THIS WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24701511 ↗
  • MalfunctionMar 23, 2026Low impedance

    IT WAS REPORTED THAT IMPEDANCES BELOW NORMAL RANGE ON UNUSED CONTACT COMBINATION 10/11. SAME RESULT WITH OLD (EXPLANTED) AND NEW (IMPLANTED) BATTERIES. SINCE THE BELOW NORMAL IMPEDANCE SHOWED IN PRE-OP AND WAS ON AN UNUSED CONTACT COMBO, THE SURGEON DID NOT PURSUE EXTRA INTERVENTIONS TO CORRECT IT AND ASSUMED THAT IT WAS LIKELY IN THE PATIENT'S WIRING. ISSUE REMAINS UNRESOLVED. NO KNOWN EXTERNAL FACTORS CONTRIBUTING TO THIS. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT CAUSE OF LOW IMPEDANCE IS UNKNOWN. BATTERY REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24663497 ↗
  • InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT EROSION WAS OCCURRING AT IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND SURGICAL INTERVENTION WILL OCCUR TO REMOVE INS/EXTENSIONS DUE TO INFECTION. MANUFACTURER REPRESENTATIVE (REP) CALLED AND HAD QUESTIONS ABOUT COMPATIBILITY BETWEEN BURR HOLE KITS, TORQUE WRENCHES, INSTRUMENTS. TECHNICAL SERVICES REACHED OUT FOR ANSWERS TO THESE QUESTIONS(SEE FOLLOW UP EMAIL TO LOCAL REP). DURING THE CALL, REP. SAID THE PATIENT (PT) INS WAS BEING REMOVED TOMORROW TO ADDRESS "EROSION AT POCKET SITE."

    Patient problems: Pocket Erosion; Unspecified Infection

    MAUDE report 24634148 ↗
  • MalfunctionMar 13, 2026Vibration; Insufficient Device Problem Information

    IT WAS REPORTED THAT PATIENT EXPERIENCED SOME TINGLING IN THEIR CHEST NEAR WHERE THE DEVICE WAS. CALLER SAID AFTERWARDS IT FELT LIKE A VIBRATING SENSATION. THE PATIENT IS AT AN ASSISTED LIVING FACILITY AND WEARS A PENDANT BECAUSE THEY ARE WHEELCHAIR BOUND. CALLER DOESN'T KNOW IF THE CAREGIVERS HAD GONE TO CLEAR THE PATIENT'S PENDANT. CALLER HAS AN APPOINTMENT WITH THE HEALTHCARE PROVIDER ON TUESDAY. CALLER WANTED TO KNOW IF THERE WAS A WAY TO CHECK THE DEVICE REMOTELY. REVIEWED OPTION TO BRING THE PATIENT IN TO THE HEALTHCARE PLAN TO HAVE THE DEVICE CHECKED.

    Patient problems: Inappropriate Device Stimulation of Tissue; Paresthesia

    MAUDE report 24598027 ↗
  • InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S DEVICE ON THE LEFT SIDE IS TURNED OFF. THE OTHER DEVICE WAS TAKEN OUT OF THEIR BODY BECAUSE THE BATTERY GOT INFECTED AND THEY HAD TO REMOVE THE BATTERY PROBABLY TWO TO THREE YEARS AGO. THE OTHER DEVICE ON THE LEFT SIDE WAS TURNED OFF BECAUSE THEY DIDN'T HAVE ANY LUCK WITH IT AND IT WASN'T WORKING FOR THEM. PATIENT THINKS IT MIGHT HAVE BEEN TURNED OFF WHEN THEY HAD THE INFECTION ON THE OTHER SIDE. WHEN ASKED WHEN THE DEVICE WAS TURNED OFF, PATIENT SAID, THEY DON'T KNOW. IT HAS PROBABLY BEEN TWO OR THREE YEARS. THE REASON FOR CALL WAS PATIENT HAS BEEN HAVING SOME ISSUES WITH THEIR FEET AND THEY WANT TO DO AN MRI. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN CLARIFYING THAT PATIENT INFECTION WAS A MRSA INFECTION AND THE RIGHT BATTERY WAS EXPLANTED ON (B)(6) 2022. AT THE TIME OF LAST VISIT ON (B)(6) 2023, LEFT GENERATOR WAS NEARING EOS AND PATIENT DID NOT HAVE A NEURO OR PSYCH PROVIDER TO TAKE OVER PROGRAMMING.

    Patient problems: Bacterial Infection

    MAUDE report 24523792 ↗
  • MalfunctionMar 4, 2026Impedance Problem; Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT THE PATIENT IS GETTING A 1703 ERROR CODE ON THEIR PATIENT PROGRAMMER. REP IS NOT SURE WHEN THE ERROR CODE STARTED. TECHNICAL SERVICE SPECIALIST REVIEWED MEANING OF THE CODE AND THE REP STATED THE PATIENT HAS KNOWN IMPEDANCE ISSUES. THE REP WAS NOT WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24512716 ↗
  • MalfunctionJan 30, 2026High impedance; Application Program Problem; Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT THE PATIENT'S EXTERNAL DEVICE IT GIVES A WARNING CODE THAT SAYS IT DOESN'T HAVE ENOUGH POWER TO PROVIDE THE RIGHT VOLTAGE OR SIGNAL THAT IT NEEDS. THE PATIENT STATED THAT THEY SAW A NEUROLOGIST APPROXIMATELY 2 WEEKS AGO AND WERE TOLD THAT THE BATTERIES WERE FUNCTIONING NORMALLY BECAUSE THEY WERE USING SUFFICIENT POWER. THE AGENT HAD THE PATIENT CONNECT TO THE INS TO FIGURE OUT THE EXACT ERROR MESSAGE THEY WERE SEEING. THE PATIENT WAS ABLE TO CONNECT AND SAW THE MESSAGE "NEUROSTIMULATOR IS PROVIDING LESS THAN THE REQUESTED THERAPY. SERVICE CODE: 1703." THE AGENT REVIEWED THE OOR MESSAGE, HAD THEM PRESS CONTINUE TO CLEAR THE ERROR, AND THEY WERE ABLE TO SEE THEIR CURRENT THERAPY SETTING. THE AGENT REFERRED THE PATIENT TO THE HCP FOR FURTHER MANAGEMENT OF THE ISSUE. THE PATIENT PROVIDED ADDITIONAL INFORMATION ON 2026-JAN-27, INDICATING THAT AN OPEN CIRCUIT WAS FOUND IN CONTACT 1B. THE MANUFACTURER REPRESENTATIVE AND THE NEUROLOGIST REMOVED CONTACT 1B FROM STIMULATION PROGRAMMING AND ADDED 2B; NO ERROR MESSAGE FOLLOWING THIS ACTION. THE ISSUE WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24224275 ↗
  • MalfunctionJan 28, 2026Failure to Deliver Energy; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S HAND IS SHAKING LIKE CRAZY AND THEY THINK IT MAY HAVE BEEN BECAUSE THE THERAPY WAS TURNED OFF. THE CALLER WAS IN GROUP A AND THE ADAPTIVE THERAPY WAS ACTIVE AND IT WOULD SPIN FOR HOURS AND HOURS. THEY SWITCHED TO GROUP B AND INCREASED THE STIMULATION, BUT THE HAND IS STILL SHAKING. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: Shaking/Tremors

    MAUDE report 24199608 ↗
  • MalfunctionJan 27, 2026Overheating of Device

    IT WAS REPORTED THAT PATIENT MENTIONED THEY FELT A LITTLE TINGLING AND A BURN IN THE AREA OF THE IMPLANT. PATIENT SAID THEY HAD EXPERIENCED THIS OFF AND ON THROUGHOUT THE YEARS AND THERE WAS NO RHYME OR REASON, SOMETIMES IT WAS STRONG AND SOMETIMES IT WASN'T. PATIENT STATED THERE WERE SOME EVENINGS THEY WOULD SIT WATCHING TV AND TELL THEIR HUSBAND IT FELT LIKE IT WAS BURNING. AGENT CONFIRMED THIS HAS BEEN ONGOING SINCE HER FIRST IMPLANT BACK IN 2018. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: Burning Sensation; Paresthesia

    MAUDE report 24192217 ↗
  • InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD A FULL SYSTEM EXPLANT DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 24121820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, P960009. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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
  • Z-0187-2009 · Jun 14, 2008 · Terminated
    Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Th

…and 4 more.

Other Stimulator, thalamic, epilepsy, implanted devices

All Stimulator, thalamic, epilepsy, implanted devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.