Percept PC BrainSenseRecalls & reported problems across all models

We found 5 models of Percept PC BrainSense by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,070 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2020 and Sep 30, 2026 — classified as 7 deaths, 948 injuries, 1,115 malfunctions.

The most frequently reported specific device problem is “High impedance” (511 reports).

5 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Percept PC BrainSense recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

2. Mar 30, 2022Open, Classified

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

   Z-1129-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · names 3 of these models · Recall details · FDA record ↗

4. Oct 19, 2021Open, Classified

   During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

   Z-0418-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. Nov 19, 2020Terminated

   A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

   Z-0612-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported Percept PC BrainSense problems

Percept PC BrainSense models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Percept™ PC BrainSense™ B35200

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  4 recalls1 death547 reports
• Percept™ PC BrainSense™ B35200

  Stimulator, thalamic, epilepsy, implanted
  1 recall5 deaths543 reports
• Percept™ PC BrainSense™ B35200

  Stimulator, thalamic, epilepsy, implanted
  1 recall478 reports
• Percept™ PC BrainSense™ B35200

  implanted subcortical electrical Stimulator (motor disorders)
  3 recalls1 death280 reports
• Percept™ PC BrainSense™ B35200

  Stimulator, electrical, implanted, for parkinsonian tremor
  222 reports

Recent Percept PC BrainSense adverse event reports

The 15 most recent reports across all models, 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 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 29, 2026Migration or Expulsion of Device

  Patient problems: Discomfort; Insufficient Information; Pain

  MAUDE report 50939869 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area

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

  MAUDE report 50932397 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924362 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

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

  MAUDE report 50923051 ↗
• InjurySep 28, 2026Electromagnetic Interference; Energy Output Problem

  Patient problems: Convulsion/Seizure

  MAUDE report 50914832 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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