Percept™ RC B35300Recalls & reported problems

Summary

The FDA's MAUDE database contains 796 adverse event reports that list this exact device (DI 00763000564346), received between Feb 20, 2024 and Sep 30, 2026 — classified as 3 deaths, 192 injuries, 601 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (209 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 796 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Impedance Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946932 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Battery Problem

  It was reported that this was the second time the patient's battery had gotten discharged completely. The caller stated the last time this happened, they took the patient to the doctor and one of the assistants was able to turn the therapy back on. Caller stated now the patient had the battery charged back up and but they were missing the communicator so they couldn't get the the therapy to turn back ON and the "patient was not the same." Caller further clarified their comment of "not the same": they said the patient couldn't walk, couldn't eat themselves and their whole body was "not the same" since last night when the therapy turned OFF when the INS battery died. A request was sent to the repair department to replace the communicator and the caller was hoping in the meantime that a manufacturer company representative (rep) could help them turn therapy back ON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 50946119 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Electrostatic Discharge

  It was reported that patient had a lightning strike in their backyard overnight and when the patient woke up in the morning, the therapy was off. Representative states they asked the patient's father if they had to charge the battery up to turn it back on and the father said no, the battery was still charged but it was off and they could connect with the patient programmer and turn the therapy back on. Representative also mentioned the patient has dystonia. Patient's father said they would have noticed if the therapy was off when the patient went to bed. The caller also mentioned that the patient called them back today and they were able to run an MRI test and all impedances were "normal".

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 50946111 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has been in the hospital for 10 days due to severe dyskinesia and the patient was told not to use the devices at this time. Therapy is currently turned off. Caller stated the patient's symptoms have dramatically increased and are in much worse shape than they were before the surgery. Caller said the patient went home for about 24-48 hours and then somewhere in between there their symptoms began to increase dramatically so they were readmitted to the hospital and have been there ever since (b)(6) 2026.

  Patient problems: Dyskinesia

  MAUDE report 50934490 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Malposition of Device

  Patient problems: Insufficient Information; Lethargy

  MAUDE report 50933206 ↗
• MalfunctionSep 28, 2026Electromagnetic Interference; High impedance; Charging Problem

  It was reported that the patient has noticed a big change in how often they are needing to charge their implant. The manufacturing representative (rep) stated that the patient has had the same settings since (b)(6) 2025 and the average recharge time is 40 minutes with having to charge every day to every other day. Prior to an MRI on (b)(6) 2025, the patient was charging every 3-4 days or even 5 days and now it's like every 2.5 days and would not deplete the battery before recharging. Upon review of recharge logs, caller said patient charged to 100% on (b)(6) 2025, the depleted down to 0% on (b)(6) 2025. On (b)(6) 2025, patient charged to 100%, but then it went back to 0% again by (b)(6) 2025. This is a new phenomenon the patient started experiencing a couple weeks after they got an MRI. After interrogating the battery, the rep found a high impedance on 9B. The impedance reading was over 5,000 ohms in monopolar and over 10, 000 ohms in bipolar. Patient had a fall on (b)(6) 2025 that was on the left side of their body and in their "forehead area," which is what started the need for getting the MRI. At the time of the fall, an impedance check was done and everything was green. The rep

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916993 ↗
• InjurySep 28, 2026Use of Incorrect Control/Treatment Settings; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916918 ↗
• MalfunctionSep 28, 2026Failure to Deliver Energy

  It was reported that about a month ago the communicator was not holding a charge. Patient has since lost the handset. Patient said their stim is off and they have no way to turn it on.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916698 ↗
• MalfunctionSep 28, 2026Use of Incorrect Control/Treatment Settings; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916603 ↗
• InjurySep 28, 2026Migration or Expulsion of Device

  It was reported that patient underwent surgery due to poor wound healing under lead/extension incision, which appeared to be red and scabbed. Patient still had scabbing and healing issues on the skin near the lead/extension connection block area from the original implant back in (b)(6) 2026. When the surgeon opened the original incision they found that the connection block had migrated directly under the incision causing wound erosion. Surgeon noted that the patients skin was already thin and somewhat difficult to close. The surgeon decided to place new extensions. The surgeon then made a pocket under the skin anterior to the incision to push the connection block away from the incision. The surgeon did not tie down the connection block to prevent it from migrating again under the incision though. The surgeon cut away the effected skin to properly close the incision. The incision was flushed out with a betadine solution, closed, and the patient was sent home with a round of antibiotics to prevent further infection.

  Patient problems: Impaired Healing; Pocket Erosion; Scar Tissue

  MAUDE report 50915262 ↗
• MalfunctionSep 25, 2026High impedance

  It was reported that patient was never given an ID Card wit their information to provide to the MRI facility. Agent reviewed MRI com patibility and offered to walk the caller through the MRI mode steps. Callers spouse was there to assist and stated that when they've attempted to use the communicator that it's never worked for them. Agent reviewed how to connect to the DBS Therapy App and the ca ller confirmed that they were able to successfully navigate into the DBS Therapy App. As agent was walking through the MRI Mode steps the caller stated that they were seeing that MRI eligibility cannot be determined information code 2621212222000 indicating open c ircuit. Agent reviewed meaning of the code and redirected the caller to the HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898424 ↗
• MalfunctionSep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892589 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50890495 ↗
• InjurySep 24, 2026Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  It was reported that patient's therapy is off as of this morning and they don't know how to turn it back on. manufacturer representative (rep) said the patient went to the hospital over the weekend and whenever the patient goes to the Hospital, the therapy turns off. Agent asked if the hospital stay was related to the device/therapy and representative said no, it was unrelated. Representative tried to connect to the DBS Therapy app on the handset but was getting the 'not found' message. Representative scanned the code on the back of the communicator and was able to connect. Representative then saw a service code 634. The issue was not resolved through troubleshooting. Agent reviewed code and advised the caller to charge the stimulator, as they are not getting therapy due to the implantable neurostimulator (INS) being low. Patient rep reported that patient can barely talk, that he can't eat, trembling and he also has abdominal pain since last Friday. Caller thinks the implant is depleted as it has for the last 4 times in the last 6 months. Handset was able to connect to the communicator after a reset, however, it go no device response. Technical Services(Ts) troubleshoot with the re

  Patient problems: Abdominal Pain; Dysphasia; Insufficient Information; Shaking/Tremors

  MAUDE report 50882991 ↗
• InjurySep 23, 2026Failure to Deliver Energy; Battery Problem; Impedance Problem

  It was reported that patient complaining of battery drain faster than expected and device turning OFF unexpectedly. This occurred after patient programming changed from cdbs to adaptive group. Rep instructed patient on how programming change can affect battery drain rate and to recharge a day or two sooner. Also instructed to turn dbs back on. HCP said impedances recently checked and are within normal limits. HCP notes that underlying anxiety may be contributing to report of issue.  Patient will monitor and change recharge interval timing and f/u with HCP for further issues. Patient is doing well per HCP on his programmed settings. Additional information was provided indicating that the manufacturer representative received a text from the patient reporting a 2703 error code while using adaptive therapy. The representative contacted the managing healthcare provider, who reported that the patient had recently been seen and was doing well with normal impedances. Technical support reviewed that 2703 indicates an out-of-range (OOR) condition and that the system cannot deliver the programmed therapy for the group currently in use. The caller was not with the patient at the time of the ca

  Patient problems: Anxiety

  MAUDE report 50871831 ↗
• MalfunctionSep 23, 2026High impedance

  It was reported that bilateral elevated impedance occurred during implantable neurostimulator (INS) to lead connection on contacts 3 and 11. Patient was asleep during procedure and no further intervention planned at this time. Connection at head was opened, clean and dried bilaterally with no change in impedance. Connection at INS was opened cleaned and dried with no change in impedance. This process was repeated with no change. New extension was opened and tested on both sides outside of the body with no change in impedance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869855 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that within the first month of the first implantable neurostimulator (INS) being implanted, their scalp never healed well and they developed a staph infection. As a result, the whole DBS system was explanted about 2 months later and this year a new DBS system was implanted. Agent documented reported event.

  Patient problems: Bacterial Infection

  MAUDE report 50820336 ↗
• MalfunctionSep 18, 2026Low impedance

  It was reported that manufacturer representative (rep)  received a report from the HCP that included normal impedances for the patients monopolar pairs but the 8/9 pair showed a value of 63ohms. Troubleshooting was not required. The issue was not resolved through troubleshooting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818886 ↗
• MalfunctionSep 17, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810603 ↗
• MalfunctionSep 17, 2026Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  It was reported that the patient normally only needs to recharge every 3-4 days, but they let the battery hit 0% on one point on accident and since then, it has been losing 40% to 50% in a single day and they are having to recharge more. Issue started about 2.5 wks ago. The caller asked if the patient had changed any programs or groups, but the caller said probably not. The patient is in Mexico City and does not have a treating neurologist there, rep stated they are unlikely to change settings. Reviewed with the caller to have the patient keep a diary of their charging interval, charging duration and start/end battery level. If the issue continues, redirect to a physician that can check the system and pull logs to check recharge history.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800858 ↗
• InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had a new battery replaced on Friday. Caller stated that when the patient was in the recovery room after the surgery, the patient experienced what they described as shocks to the left side of their body 2-3 times. Caller said the shocks stopped when patient was sitting up, but since then the patient has been getting shocks occasionally when they are lying down. Caller mentioned that they put a message into the patient's doctor and messaged the neurologist, and talked to a person from the surgical team who told them that it couldn't possibly be caused by the battery, but the primary neurologist was less definite about what the cause might be. Agent reviewed that we can't rule out that it's not the DBS that is causing the shocks, and reviewed options to turn stimulation down or off. Caller did not know if the doctor had given any advice to turn stim down, and said they hadn't tried to control the device for monitoring yet. Caller stated that the patient does not want anyone outside the healthcare provider making adjustments to the stim. Caller stated that they would read the manual and call Patient Services back if they decide to turn the implantable

  Patient problems: Electric Shock

  MAUDE report 50789801 ↗
• InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had a new battery replaced on Friday. Caller stated that when the patient was in the recovery room after the surgery, the patient experienced what they described as shocks to the left side of their body 2-3 times. Caller said the shocks stopped when patient was sitting up, but since then the patient has been getting shocks occasionally when they are lying down. Caller mentioned that they put a message into the patient's doctor and messaged the neurologist, and talked to a person from the surgical team who told them that it couldn't possibly be caused by the battery, but the primary neurologist was less definite about what the cause might be. Agent reviewed that we can't rule out that it's not the DBS that is causing the shocks, and reviewed options to turn stimulation down or off. Caller did not know if the doctor had given any advice to turn stim down, and said they hadn't tried to control the device for monitoring yet. Caller stated that the patient does not want anyone outside the healthcare provider making adjustments to the stim. Caller stated that they would read the manual and call Patient Services back if they decide to turn the implantable

  Patient problems: Electric Shock

  MAUDE report 50789798 ↗
• MalfunctionSep 16, 2026Communication or Transmission Problem

  It was reported that information was received from a patient regarding an external device. The reason for call was that the caller reports that they are having trouble with the recharger. The caller indicates that the connection keeps breaking between the recharger and INS all the time and it takes forever to charge the implanted neurostimulator. The issue has been going on for "quite a while" and it seems to be getting worse. They have not had any falls, trauma, or significant changes to weight. Helped caller use the recharger without the drape and after repositions they were able to see excellent connection and go from 90% to 100% while on the call. Caller noted that the harness is too big for them and it feels like it is strangling them. A smaller drape was sent. The caller will continue to monitor recharging. The caller was not able to find the serial number of the recharger on the handset and agent did not want them to pull it away to get the serial number off the back. Additional update was received from patient stating the replacement device was better but still it was too long and they just held it in place while being laid down.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785098 ↗
• InjurySep 15, 2026Failure to Deliver Energy; Energy Output Problem

  Patient problems: Discomfort

  MAUDE report 50782228 ↗
• MalfunctionSep 15, 2026Failure to Deliver Energy; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778038 ↗

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.