Percept™ PC BrainSense™ B35200 (UDI 00763000642174)Recalls & reported problems

Summary

The FDA's MAUDE database contains 543 adverse event reports that list this exact device (DI 00763000642174), received between Feb 24, 2023 and Sep 29, 2026 — classified as 5 deaths, 250 injuries, 288 malfunctions.

The most frequently reported specific device problem is “High impedance” (147 reports).

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

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.

Recalls naming this device

1. May 15, 2024Open, Classified

   Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

   Z-2427-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 543 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain; Sleep Dysfunction

  MAUDE report 50932397 ↗
• MalfunctionSep 25, 2026High impedance

  It was reported that information was received from a manufacturer representative stating the patient needed an MRI and was showing o ut-of-range impedances on the left VIM, with a monopolar value of 3877 and a bipolar value of 3780. The caller inquired whether the patient could undergo MRI. When asked whether the issue had been documented previously, the caller stated they believed it had been this way for a long time but were not certain, reporting the event may have originated approximately seven to eight years earlier. MRI compatibility information was reviewed with the caller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893387 ↗
• MalfunctionSep 24, 2026Malposition of Device

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

  MAUDE report 50892168 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had some complications with lead exposure from 2023 due to persistent escare that was treated with wound care and antibiotics due to complications

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50869134 ↗
• InjurySep 14, 2026Failure to Deliver Energy

  It was reported that patient (pt) called in for assistance linking the implantable neurostimulator (INS). Reviewed info and patient was able to link the INS. Patient said they wished we were open on the weekend because they were shaking all weekend because the INS was off. Patient was putting the handset on the INS not the communicator.

  Patient problems: Shaking/Tremors

  MAUDE report 50754932 ↗
• InjurySep 3, 2026Device Difficult to Program or Calibrate; Loss of Data

  It was reported that the caller stated that they were also having an issue with their settings. Caller stated that they are not able to change groups and one of the groups that they had as an option disappeared. Caller stated that they were unsure when the last time they saw the HCP. Caller also stated that something in the settings causes a burning sensation in their mouth. Caller had questions about the aDBS feature and stated that they talked to the HCP about the aDBS but the aDBS was never programmed. Agent had the caller reviewed therapy settings and caller confirmed that they were on continuous stim and not aDBS.

  Patient problems: Burning Sensation; Shaking/Tremors

  MAUDE report 50587537 ↗
• MalfunctionSep 2, 2026Failure to Deliver Energy; High impedance; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571291 ↗
• InjuryAug 23, 2026High impedance; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  It was reported that  the patient saw service code 1703 on Sunday. Caller said the patient had been feeling off. Caller said the patient was feeling like their tremors were worse. Caller said the patient was having a little chest discomfort on the side where the implantable neurostimulator (INS)  is which usually indicates they need to increase stim. Caller said the programmer was not letting the patient turn stim off. Caller said the patient went through the process of trying to turn stim off and not being able to then the chest pain went away. Caller said the patient hasn't had any falls trauma or change in activity. Caller said they contacted the HCP and were advised to call manufacturer. The caller stated that the patient was getting codes 1703 and 1098 on the patient remote. tech services reviewed meaning of the codes. The caller will follow-up with the HCP. HCP called in with additional information. HCP said patient mentioned they got an error message over the weekend that said the patient's neurostimulator were delivering less therapy than requested and then the patient started experiencing a shock-like sensation in their right chest and back that occurred with any movement.

  Patient problems: Discomfort; Electric Shock; Insufficient Information; Shaking/Tremors

  MAUDE report 50397613 ↗
• MalfunctionAug 21, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Nervous System Problem

  MAUDE report 50379191 ↗
• MalfunctionAug 18, 2026Low impedance; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291523 ↗
• InjuryJul 30, 2026Electromagnetic Interference

  It was reported that they are at the hospital and turned the device off for an MRI and trying to turn it back on after the scan, and when they do they had numbness on their face, so they turned it back off but when they turned it back on, they had the same symptoms. Agent reviewed that they might want to give it some more time after turning the therapy back on until the patient's body could adjust to the stimulation. They turned the therapy back on during the call and gave it a few minutes and the patient felt better. The MRI staff had already reached out to the manufacturer representative (rep) and neurologist and will only send the patient home once they hear back from the neurologist. They will continuously monitor the issue. Agent documented reported events.

  Patient problems: Numbness

  MAUDE report 50083789 ↗
• InjuryJul 30, 2026Environmental Compatibility Problem

  It was reported that the patient had been complaining that every time they went outside and in the sun, they felt very hot in their head. The issue started about a month ago. At their last appointment with their healthcare provider (HCP) about 3 weeks ago, the HCP told them that the system was ok, but they did not inform the HCP about the heat. Patient services agent tried to confirm if this correlated with a settings change, but they made it seemed like it correlated to outside temperature. They were redirected to their HCP.

  Patient problems: Burning Sensation

  MAUDE report 50082716 ↗
• InjuryJul 30, 2026Environmental Compatibility Problem

  It was reported that the patient had been complaining that every time they went outside and in the sun, they felt very hot in their head. The issue started about a month ago. At their last appointment with their healthcare provider (HCP) about 3 weeks ago, the HCP told them that the system was ok, but they did not inform the HCP about the heat. Patient services agent tried to confirm if this correlated with a settings change, but they made it seemed like it correlated to outside temperature. They were redirected to their HCP.

  Patient problems: Burning Sensation

  MAUDE report 50082681 ↗
• InjuryJul 29, 2026Electromagnetic Interference; Therapy Delivered to Incorrect Body Area

  It was reported that  patient said they have been having dizziness, falling. Patient said is started the last part of last year and they had one that they caught on film on (b)(6) and that was when they started taking them seriously. Patient was told they couldn't drive for 6 months and if they are rear ended or fall they could be paralyzed from C1 down because their cervical spine is so messed up. The patient was redirected to their healthcare provider to further address the issue. Patient also noted when they walked under power line they feel a "power buzzing kind of thing" in their chest.

  Patient problems: Dizziness; Fall; Inappropriate Device Stimulation of Tissue; Insufficient Information

  MAUDE report 50072326 ↗
• MalfunctionJul 15, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828201 ↗
• MalfunctionJul 15, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Ambulation or Postural Difficulties; Electric Shock; Fall; Pain; Unspecified Nervous System Problem

  MAUDE report 25825989 ↗
• MalfunctionJul 8, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752472 ↗
• MalfunctionJul 8, 2026High impedance

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT ELEVATED IMPEDANCES WERE OBSERVED ON BOTH LEADS. PRIOR TO GENERATOR REPLACEMENT, CONTACT 0 WAS WITHIN NORMAL LIMITS, AND CONTACT 1 WAS ELEVATED; AFTER REPLACEMENT, CONTACT 0 WAS ELEVATED, AND CONTACT 1 WAS WITHIN NORMAL LIMITS. THE PHYSICIAN ATTEMPTED A CLEAN AND DRY AT THE IPG CONNECTION POINT WITH NO CHANGE IN IMPEDANCE VALUES. THE PHYSICIAN IS AWARE OF THE FINDINGS, AND NO FOLLOW-UP IS PLANNED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP CLARIFIED THE INSS WERE REPLACED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752468 ↗
• MalfunctionJun 18, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT A PATIENT STATED A SERVICE CODE 1703 'AN OUT OF RANGE (OOR) SITUATION HAS OCCURRED" WAS DISPLAYED INDICATING THERAPY WAS NOT PROVIDING THE EXPECTED AMOUNT OF STIMULATION. THE PATIENT REPORTED THEY WERE ABLE TO BYPASS THE MESSAGE. TROUBLESHOOTING INFORMATION WAS REVIEWED AND THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543230 ↗
• MalfunctionJun 15, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THEY HAD AN MRI ON (B)(6) FOR A BACK PROBLEM. AFTER THAT THEY HAD MIGRAINES EVERY DAY FOR AT LEAST 2 WEEKS WHICH IS NOT NORMAL FOR THEM. PATIENT STATED SOMEONE FROM MANUFACTURER COME TO TURN THE DBS OFF BEFORE THE MRI BUT THE EMPLOYEE TOLD THE PATIENT "WE DON'T SHUT IT ALL THE WAY OFF". PATIENT SERVICES REVIEWED EXPECTATIONS THAT THIS MAY OCCUR WHEN AN MRI GROUP IS CONFIGURED HOWEVER PATIENT WAS NOT FAMILIAR AND DID NOT KNOW IF THEY HAD AN MRI GROUP OR NOT. PATIENT DID NOT KNOW THE NAME OF THE REP WHO WAS PRESENT AT THEIR MRI. PATIENT BELIEVES THE DBS IS STILL WORKING BECAUSE THEY SHAKE IF IT IS NOT ON AND THEY CAN TELL IT IS WORKING WHEN THEY TURN IT BACK ON. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THEIR CONCERNS WITH MIGRAINES.

  Patient problems: Headache

  MAUDE report 25504047 ↗
• MalfunctionJun 9, 2026High impedance; Unintended Collision; Battery Problem; Therapeutic or Diagnostic Output Failure

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE HIGH IMPEDANCE MAY BE RELATED TO A FALL AND THAT THE ISSUE IS CONSIDERED RESOLVED, ALTHOUGH A HIGH IMPEDANCE VALUE REMAINS ON CONTACT 10A. THE SHORTENED BATTERY LONGEVITY TO FIVE MONTHS WAS ATTRIBUTED TO THE CONTINUED USE OF CONTACT 10A WITH HIGH IMPEDANCE. HIGH IMPEDANCE WAS IDENTIFIED AS THE CONTRIBUTING FACTOR; NO ADDITIONAL STEPS BEYOND THOSE PREVIOUSLY DESCRIBED WERE REPORTED. THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25450230 ↗
• MalfunctionJun 9, 2026Electromagnetic Interference; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CARDIOVERSION OR DEFIBRILLATION ON THE (B)(6) AND NOW, PATIENT CANNOT CONNECT TO IMPLANTABLE NEUROSTIMULATOR (INS) IN THERAPY APP ON HANDSET SINCE FRIDAY, (B)(6) HCP SAID THEY GOT THE DEVICE NOT FOUND MESSAGE WHEN THEY TRIED TO CONNECT THE COMMUNICATOR TO THE IMPLANTED NEUROSTIMULATOR. DURING THE CALL, THE PATIENT REPRESENTATIVE RESTARTED THE HANDSET AND RESET THE COMMUNICATOR, BUT THE PATIENT WAS STILL UNABLE TO CONNECT. THE SEARCHING FOR DEVICE KEPT SPINNING AND HANDSET NEVER ADVANCED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT REP CALLED REPEATING PREVIOUSLY REPORTED EVENT INFORMATION ASKING FOR TROUBLESHOOTING ASSISTANCE. THE FOLLOWING TROUBLESHOOTING STEPS WERE PERFORMED ON THE CALL: CLOSED OUT OF ALL RUNNING APPLICATIONS, CONFIRMED BLUETOOTH AND LOCATION WERE ENABLED, HARD RESET THE COMMUNICATOR. WHEN CALLER REOPENED THE MYDBS THERAPY APPLICATION AND TAPPED CONNECT THE HANDSET WAS ABLE TO CONNECT TO THE COMMUNICATOR BUT THEY ENCOUNTERED MESSAGE PROMPTING THEM TO SET UP LINKS. REVIEWED STEPS TO PLACE THE COMMUNICATOR AGAINST THE INS AND PRESS START. THE SEARCHING FOR DEVICE MESSAGE WAS SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446526 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF PRIOR TO A PROCEDURE. THEY ARE NOT SURE IF THERAPY WAS TURNED BACK ON AND NOW THE PATIENT IS "PROFOUNDLY PARKINSONIZED". THE PATIENT HAS BEEN IN AN OUT OF THE ICU ABOUT ALMOST ONE MONTH DURING THAT TIME THE PATIENT HAS HAD DELIRIUM AND PARKINSON'S SYMPTOMS. THE CALLER STATED THAT BECAUSE OF THE PATIENT'S CONDITION IT WAS DIFFICULT TO DETERMINE WHEN THE SYMPTOMS BEGAN. THE CALLER USED THE PATIENT REMOTE TO CONNECT TO THE INS AND CONFIRM THAT THERAPY WAS ON. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES DIRECTED THE CALLER TO FOLLOW-UP WITH THE NEUROLOGIST TO CONSIDER PROGRAMMING CHANGES TO ADDRESS THE PARKINSON'S SYMPTOMS.

  Patient problems: Cognitive Changes; Insufficient Information

  MAUDE report 25283217 ↗
• MalfunctionMay 26, 2026High impedance

  IT WAS REPORTED THAT PATIENT HAS AN UPCOMING MRI AND THE NEUROLOGIST DIDN'T SIGN OFF ON THE FORM BECAUSE OF AN IMPEDANCE ISSUE. REPRESENTATIVE SAID THEY TRIED INCREASING STIMULATION ON 2C AND IN RING MODE AND RUNNING IT AT 1.0 MA, BUT THEY COULDN'T GET THE IMPEDANCE TO CLEAR. THE ISSUE WAS FIRST NOTICED ABOUT 2 WEEKS AGO. PATIENT HAD MRI I 2025, AND IMPEDANCE WAS GOOD AT THE TIME. THE IMPEDANCE CE LEVEL WAS GREATER THAN 5,000, BUT WHEN THEY RAN IT ON AUTOMATIC, IT GAVE THEM A VALUE OF LIKE 21,000. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. TECHNICAL SERVICES REVIEWED THAT MRI IS NOT RECOMMENDED. ALSO REVIEWED WITH REP THAT IF HCP WANTS TO OVERRIDE THE RECOMMENDATION, THEN IT'S UP TO THE HCP, BUT MANUFACTURER CANNOT RECOMMEND PROCEEDING WITH THE MRI. THE PATIENT AND PATIENT REP CALLED WITH FOLLOW UP QUESTIONS REGARDING REPORTED IMPEDANCE ISSUES STATING THAT THE REP NEVER FOLLOWED UP WITH THEM TO DISCUSS NEXT STEPS TO ADDRESS HIGH IMPEDANCES. CALLER WANTED TO KNOW IF MEDICAL AFFAIRS WOULD OVERRIDE THE IMPEDANCE DECISION FOR MRI ELIGIBILITY, REDIRECTED TO MANAGING HCP. CALLER INDICATED THEY HAD ALREADY SPOKEN TO MANAGING HCP AND WERE TOLD THE

  Patient problems: Insufficient Information; Shaking/Tremors; Visual Impairment

  MAUDE report 25278181 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S (PT) PREVIOUS DBS DEVICE WAS REMOVED ON (B)(6) 2024 BECAUSE IT DID NOT DO WHAT IT WAS SUPPOSED TO DO. PATIENT SAID THEY HAD THE PREVIOUS DEVICE FOR A YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25259831 ↗

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-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-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.