Percept™ PC BrainSense™ B35200 (UDI 00763000916268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 00763000916268), received between Aug 21, 2024 and Sep 30, 2026 — classified as 102 injuries, 120 malfunctions.

The most frequently reported specific device problem is “High impedance” (53 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50953685 ↗
• InjurySep 29, 2026Migration or Expulsion of Device

  Patient problems: Discomfort; Insufficient Information; Pain

  MAUDE report 50939869 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924362 ↗
• MalfunctionSep 23, 2026Impedance Problem; Insufficient Device Problem Information

  It was reported that the MRI technologists had tried putting the INS into MRI mode and were seeing a code 2531 2212 22 0000. Rep wanted to know what the code meant. Technical services informed the manufacturing representative (rep) that code was indicating a short circuit was detected during the MRI impedance test. Caller noted that they drove to the MRI center and ran the impedance test twice with their tablet, and it came back normal. with a reading of 319 ohms. However, when they went back to the suite to put the patient into MRI mode, contact 9 came back with an impedance of 52 ohms and it so they could not put it in MRI Mode. Caller wanted to know how to avoid this in the future. Agent reviewed that the tablet can run at a higher level versus the handset. But there isn't a way to avoid an intermittent impedance. In this case, it was a good thing that impedance was checked multiple times. Contact 9 isn't being used in programming so there was no impact on patient's therapy. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870302 ↗
• InjurySep 23, 2026Energy Output Problem

  It was reported that patient experienced a psychosis episode while being home. Patient called the police because he thought his wife was his mom and thought they were trying to take him to an insane asylum. Patient does not remember doing this.  Patient is responding to the DBS and the severity of his seizures has reduced. HCP reduced the patient¿s DBS significantly because she thinks that he was overstimulated and that the DBS was causing it. Patient will return to HCP office in October.

  Patient problems: Cognitive Changes; Device Overstimulation of Tissue

  MAUDE report 50869441 ↗
• MalfunctionSep 23, 2026High impedance

  It was reported that impedance was high on contacts 3 and 11 and remain unresolved at this time. See 709400266 for previous battery shocking sensation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868528 ↗
• InjurySep 22, 2026Energy Output Problem; Battery Problem

  Patient problems: Insufficient Information

  MAUDE report 50858943 ↗
• InjurySep 21, 2026Overheating of Device

  Patient problems: Alteration in Body Temperature; Burning Sensation; Discomfort

  MAUDE report 50847758 ↗
• MalfunctionSep 17, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810253 ↗
• MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794715 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50794620 ↗
• InjurySep 16, 2026Material Deformation; Therapeutic or Diagnostic Output Failure

  Patient problems: Shaking/Tremors; Twiddlers Syndrome

  MAUDE report 50791884 ↗
• InjurySep 14, 2026Low impedance

  Additional information was reported by the manufacturing representative (rep) regarding the previously reported low impedance issue. Rep stated that the low impedance is on bipolar 9<(>&<)>10. The contacts that are low are not being used for therapy for the patient. The patient stated they are doing well on these settings and symptoms are well controlled. Patient was attempting to get an MRI where they live and was told they could not due to having impedances out of range(low). They decided to see a doctor for a second opinion. No actions are planned at this time and this issue remains unresolved. The new surgeon the patient is seeing will weigh the risks/benefits with the patient and follow up with rep if a revision will be scheduled.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759486 ↗
• InjurySep 14, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Cognitive Changes; Discomfort; Electric Shock; Neuropathy; Shaking/Tremors

  MAUDE report 50759175 ↗
• MalfunctionSep 14, 2026High impedance; Low impedance

  It was reported that when running impedance check once battery and lead/extensions were connected the segment 1B had high impedances, short circuit which did not clear despite all problem solving methods. Attempted to disconnect and reconnect lead/extension end and also to re insert lead and wipe off and plug back into battery port. Checked set up, re ran impedance at various measurements. Attempted to run stimulation through segment. Unable to clear impedance issue. Manufacturer representative (rep) reports the issue was not resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755193 ↗
• MalfunctionAug 27, 2026High impedance; Patient Device Interaction Problem

  It was reported that patient had a high impedance values of >5000ohms with segment 9b. The caller indicated that the impedance issue was discovered when the implantable neurostimulator (INS) was interrogated today. The patient reported that they hit their head in July and the caller thought that may be related to the impedance issue. The caller reported that they sent log files to engineering. Troubleshooting was not required. The issue was not resolved through troubleshooting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485992 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient stated the DBS system had been removed due to recurrent infections occurring two to three times. The patient reported being hospitalized from Christmas Eve to Christmas Day, at which time the implanted neurostimulator battery was removed and a "cord" was left in place in an emergency situation. The patient stated that several weeks later the cord became infected, resulting in another hospitalization for approximately five days, and they removed the cord. The patient reported that after the infection initially appeared to clear, a new DBS system was implanted, but the patient did not realize it had become affected. The patient also stated that they still have the stitches now, and they were later readmitted because the antibiotics being given were not effective against the bacteria involved, and a PICC line was placed to administer a different medication. See PE 709016640 for infection/explant/ leads remained/re-implantation planned.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 50314541 ↗
• InjuryAug 17, 2026Failure to Deliver Energy

  It was reported that the battery has been going dead and said that shakes so bad and is having difficulty connecting to the implant. Patient also mentioned has high anxiety. With instruction, patient tried to connect to the DBS therapy application however was unable to connect. Patient said that received something about links, said might have hit the wrong button before. When asked, patient said doesn't have anyone to assist with the external devices and doesn't have anyone that he can contact. The issue was not resolved through troubleshooting. Agent suggested patient contact their managing physician however patient said that the managing physician left however does work with the nurse practitioner. The patient mentioned contacting the ambulance. Patient was directed to seek medical attention. Patient did attempt to try to connect again however began very agitated and said isn't able to do this anymore and ended the call.

  Patient problems: Anxiety; Shaking/Tremors

  MAUDE report 50282230 ↗
• InjuryJul 29, 2026Data Problem

  It was reported that  patient had a throbbing on their head after increasing the stimulation on both sides. Caller also stated that the patient hasn't used the control device for a while, and they connected to the implantable neurostimulator (INS)  today but it looks like the therapy screen is not reflecting the original "number" (therapy setting) that the HCP had set on, so they pressed revert therapy, and was asking if that would be okay. Agent reviewed that the external devices functions separately from the INS, and redirected them to the HCP to further address the issue.

  Patient problems: Discomfort

  MAUDE report 50073480 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient has had a serious complication with their device. Caller mentioned patient had a non rechargeable device implanted about 18 months ago to replace a rechargeable device that they were having trouble with. Caller mentioned patient has dementia and got device for essential tremor. Caller mentioned patient has had implants replaced in the past. Caller reported they noticed a sore on patient's right chest wall kind of right by where the implant battery is (caller stated implant is subcutaneous placement). Caller stated it didn't look severe, but it was like a red blotch that became worse and worse. Caller clarified it was a red spot that looked like a little skin lesion and stated they thought maybe it was just a bruise or skin lesion or something that was noted on (b)(6). Caller stated patient had appointment with HCP, patient's "dementia person", then went to their movement disorder clinic to look at the skin lesion and their healthcare providers did not know what it was. Caller stated they watched it and the device broke through patient's skin so the doctor removed it due to potential for infections. Caller stated patient is currently inpatient at (b)(6)

  Patient problems: Hematoma; Pocket Erosion; Shaking/Tremors; Unspecified Infection

  MAUDE report 50057640 ↗
• MalfunctionJul 14, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812935 ↗
• MalfunctionJul 6, 2026Energy Output Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT (PT) SAID THEY USED TO LEAVE BOTH SIDE STIMULATORS TURNED ON ALL THE TIME AND ABOUT A MONTH AGO THEIR DOCTOR INSTRUCTED THEM TO START TURNING THEM OFF AT NIGHT AND BACK ON AGAIN IN THE MORNING SO PATIENT HAS BEEN DOING THAT EVER SINCE. PT SAID THEY HAVE 2 SETS OF EXTERNAL EQUIPMENT, ONE FOR EACH SIDE, THE RIGHT SIDE WORKS EASILY TO TURN THERAPY OFF/ ON AND THE LEFT SIDE WORKS GREAT IN THE MORNING TO TURN THERAPY ON BUT AT NIGHT WHEN THEY TRY TO TURN THE LEFT SIDE OFF, THEY HAVE A LOT OF TROUBLE, THEY CONTINUOUSLY GET NO DEVICE RESPONSE AND IT CAN TAKE THEM 15 MINUTES OF STRUGGLING AND TURNING THEIR COMMUNICATOR / HANDSET OFF AND BACK ON BEFORE THEY CAN FINALLY TURN THERAPY OFF ON THE LEFT. PT SAID IT IS SET UP SO THEY HAVE TO HOLD THEIR COMMUNICATORS AGAINST THEIR DEVICES TO TURN THERAPY OFF/ON BUT LAST NIGHT IT FINALLY WORKED WHEN THEY WERE HOLDING IT ABOUT 2 INCHES AWAY FROM THEIR INS. WORKED WITH PT TO TROUBLESHOOT THE LEFT SIDE EQUIPMENT AND PT SUCCESSFULLY SYNCHED TO THEIR INS, CONFIRMING THERAPY WAS ON THE IR INS BATTERY HAD MORE THAN 2 YEARS LEFT BUT ENCOUNTERED NO DEVICE RESPONSE EACH TIME THE HELD THEIR COMMUNICATOR AGAINS THEIR BODY AND TRIED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714746 ↗
• MalfunctionJul 2, 2026High impedance

  IT WAS REPORTED THAT IMPEDANCE ISSUES WERE OBSERVED DURING AN EXTENSION IMPLANTATION PROCEDURE. DURING THE PROCEDURE, IMPEDANCE ISSUES WERE NOTED ON BOTH SIDES. TROUBLESHOOTING STEPS INCLUDED DISCONNECTING THE EXTENSIONS FROM THE LEADS, CLEANING AND SUCTIONING THE PORTS, AND RECONNECTING THE COMPONENTS; HOWEVER, THE ISSUES PERSISTED. THE EXTENSIONS WERE ALSO DISCONNECTED FROM THE IMPLANTED PULSE GENERATOR, AND THE SAME CLEANING AND RECONNECTION PROCESS WAS REPEATED WITHOUT RESOLUTION. ADDITIONAL IMPEDANCE CHECKS PERFORMED DURING THE REMAINDER OF THE PROCEDURE SHOWED SOME ELECTRODES RETURNING TO NORMAL VALUES, ALTHOUGH NOT ALL CONTACTS CLEARED. IMPEDANCE ISSUES WERE REPORTED TO CONTINUE FOLLOWING COMPLETION OF THE SURGERY. THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE IMPEDANCES WERE HIGH AND THAT, DUE TO THE SEGMENTED PATTERN OF THE IMPEDANCE FINDINGS, AN AIR BUBBLE IN THE BRAIN WAS CONSIDERED A LIKELY CONTRIBUTING FACTOR. RESOLUTION STATUS AND PATIENT OUTCOME WERE NOT KNOWN. THE INFORMATION WAS CONFIRMED BY THE PROVIDER IN THE OPERATING ROOM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700392 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I THE CALLER ADDED THAT THE PATIENT ENDED UP IN THE HOSPITAL (REASON FOR HOSPITALIZATION WAS NOT PROVIDED). THE CALLER MENTIONED THAT THE PATIENT HAD A MELTDOWN YESTERDAY, BUT DID NOT PROVIDE FURTHER CONTEXT. PATIENT REPORTED THEY ARE "SHAKING LIKE HELL".

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 25696957 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTED DEEP BRAIN STIMULATION SYSTEM EXPERIENCED AN INFECTION THAT WAS REPORTED AS UNRELATED TO ANY EXTERNAL FACTOR. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. SURGICAL INTERVENTION WAS PERFORMED, AND ALL DEEP BRAIN STIMULATION COMPONENTS WERE EXPLANTED AT THE PATIENT¿S REQUEST TO ADDRESS THE INFECTION. THE ISSUE WAS REPORTED AS RESOLVED AT THE TIME OF THE REPORT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 25683884 ↗

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.