Activa® RC 37612 (UDI 00643169105492)Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00643169105492), received between Jan 18, 2017 and May 15, 2026 — classified as 2 deaths, 113 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND INFLAMMATION AT THE IMPLANT SITE AND THE DEVICE WAS EXPLANTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25191861 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SCALP ULCERATION AND FOREIGN-BODY REJECTION WAS REPORTED TO HAVE OCCURRED AT THE END OF 2023. ALL IMPLANTED SYSTEM COMPONENTS WERE EXPLANTED TO ADDRESS THE REPORTED ULCERATION AND REJECTION. THE INDIVIDUAL WAS REPORTED ALIVE WITH NO INJURY, AND THE ISSUE WAS REPORTED AS RESOLVED.

  Patient problems: Foreign Body Reaction; Skin Erosion

  MAUDE report 24927852 ↗
• MalfunctionApr 10, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THEY HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842744 ↗
• MalfunctionMar 26, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ADAPTER'S METAL HEAD HAD DETACHED. THE DEVICE WAS REPLACED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706478 ↗
• MalfunctionMar 24, 2026Connection Problem; Material Integrity Problem

  DEVICE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674524 ↗
• MalfunctionFeb 16, 2026High impedance

  IT WAS REPORTED THAT PHYSICIAN REPORT ELEVATED IMPEDANCE ON CONTACT 0. NO TROUBLESHOOTING WAS PERFORMED AND THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED FROM REP CLARIFYING THAT THEY'RE WONDERING IF PATIENT CAN HAVE MRI IF THEY HAVE AN IMPEDANCE VALUE ON ONE SIDE THAT IS A LITTLE HIGH. CALLER IS LOOKING FOR GUIDANCE TO PASS ALONG TO THE HCP AND STATED THAT CONTACT 0 IS 2705 OHMS UNIPOLAR. CALLER STATES PT HAS ALWAYS HAD "VERY CLOSE" TO HIGH IMPEDANCES, AROUND 3000 BUT BELOW 5000 AND NOTED THE IMPEDANCE VALUES HAVE NOT INCREASED OVER TIME. CALLER NOTED PT HAD A KNEE MRI TWO YEARS AGO WHICH WENT FINE BUT NOW PT IS NEEDING CARDIAC MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24351023 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO INFLAMMATION. THE ISSUE RESOLVED FOLLOWING DEVICE REMOVAL. NO INFECTION, DEATH, OR OTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 23909130 ↗
• MalfunctionDec 10, 2025Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A RECHARGER MALFUNCTION. SPECIFICALLY, THE ADAPTER'S METAL CONNECTOR DETACHED. THE DEVICE WAS REPURCHASED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771842 ↗
• InjuryNov 6, 2025Failure to Interrogate; Charging Problem; Communication or Transmission Problem; Failure to Interrogate; Charging Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ALL EXTERNAL DEVICES WERE UNABLE TO CONNECT TO THE STIMULATOR, INCLUDING BOTH PATIENT PROGRAMMERS AND CLINICIAN PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486958 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH DYSTONIA WHO UNDERWENT DEEP BRAIN STIMULATION DEVELOPED AN INFECTION AT THE SITE OF THE HEAD LEAD. THE INFECTION WAS REPORTED BY THE PATIENT'S FAMILY, AND THE ENTIRE DEEP BRAIN STIMULATION SYSTEM WAS EXPLANTED IN 2024. THE ISSUE WAS RESOLVED FOLLOWING EXPLANTATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23310875 ↗
• MalfunctionSep 2, 2025Battery Problem; Connection Problem; Material Integrity Problem; Power Problem; Battery Problem; Connection Problem; Material Integrity Problem; Power Problem

  ADDITIONAL INFO RECEIVED FROM PATIENT THAT THE ISSUE WAS RESOLVED- WIRES WERE EXPOSED AND PIN WAS BENT AND REPLACEMENT EQUIPMENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935644 ↗
• InjuryAug 11, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. DUE TO THE PATIENT'S STIMULATOR NOT BEING UPGRADED, THE BATTERY LIFE ENDED IN THE NINTH YEAR OF USE. THE REPLACEMENT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770850 ↗
• MalfunctionAug 5, 2025Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING A STINGING SENSATION ABOVE THE IMPLANT SITE, PARTICULARLY DURING RECHARGING, WHICH IS DESCRIBED AS FEELING LIKE AN ELECTRICAL SHOCK. THIS ISSUE HAS BEEN ONGOING FOR THE PAST COUPLE OF YEARS. THE PATIENT EXPRESSED CONCERN ABOUT THE POSSIBILITY OF A FRACTURE AND NOTED THAT THE IMPLANT HAS BEEN SHIFTING SINCE APPROXIMATELY 2021, WITH THE SKIN OVER THE IMPLANT APPEARING VERY THIN. THE PATIENT ALSO REPORTED THAT IN (B)(6) 2023, AFTER DEVELOPING PNEUMONIA AND COUGHING FREQUENTLY, THEIR OCD SYMPTOMS WORSENED ABRUPTLY. THE PATIENT MENTIONED SEEING A HEALTHCARE PROVIDER, WHO INDICATED THAT IMPEDANCES APPEARED NORMAL. THE PATIENT, LACKING A CURRENT MANAGING PHYSICIAN, HAS EXPERIENCED DIFFICULTY FINDING A NEW PROVIDER DUE TO HAVING RECEIVED THE IMPLANT FOR OCD. DEVICE INFORMATION WAS REVIEWED, AND THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER FOR FURTHER EVALUATION AND MANAGEMENT OF THEIR CONCERNS.

  Patient problems: Electric Shock; Pneumonia; Skin Inflammation/ Irritation

  MAUDE report 22710873 ↗
• MalfunctionJul 9, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF PARKINSON'S DISEASE EXPERIENCED AN ISSUE FOLLOWING A DEEP BRAIN STIMULATION PROCEDURE WITH THE ACTIVA RC IMPLANTABLE NEUROSTIMULATOR. THE PATIENT REPORTED THAT THE IMPLANT WAS HOT. THEY WERE ADVISED TO RETURN TO THE HOSPITAL FOR EXAMINATION AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 22458477 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPOSED THROUGH THEIR SKIN AND SCAR. THE PATIENT WOULD GO TO THE EMERGENCY ROOM BUT THE ISSUE WASN'T RESOLVED. THE NEUROSURGEON WAS PLANNING ON A REMOVAL.

  Patient problems: Pocket Erosion

  MAUDE report 22284598 ↗
• InjuryJun 4, 2025High impedance; Impedance Problem; Insufficient Device Problem Information; High impedance; Impedance Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT POTENTIAL IMPEDANCE ISSUES WERE IDENTIFIED AND A POSSIBLE EXTENSION REVISION WAS SET FOR (B)(6) 2025. NO DIAGNOSTICS OR IMAGING WERE CONDUCTED AT TIME OF REPORT.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144940 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTED AREAS OF THE STIMULATORS IN THE HEAD, BEHIND THE EARS AND IN THE ABDOMEN HAD BEEN FESTERING AND OOZING YELLOW LIQUID. THEY CONTACTED THE DOCTOR AND THEY RECOMMENDED EXPLANT. THE ISSUE WAS SAID TO BE RESOLVED.

  Patient problems: Purulent Discharge

  MAUDE report 22011516 ↗
• MalfunctionApr 23, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE REP CLARIFIED THAT THE PATIENT TURNED THEIR BATTERY OFF ON THEIR OWN BECAUSE THEY FELT THE THERAPEUTIC EFFECT WAS NOT GOOD. IT WAS UNKNOWN IF THE POOR EFFECT RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21891571 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH PARKINSON'S DISEASE EXPERIENCED AN INFECTION AND REJECTION FOLLOWING SURGERY INVOLVING THE IMPLANTABLE NEUROSTIMULATOR. THE DEVICE WAS SUBSEQUENTLY EXPLANTED. NO SURGICAL INTERVENTION WAS PLANNED OR OCCURRED BEYOND THE EXPLANTATION. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 21720230 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE DEVICE REJECTION WAS UNKNOWN.

  Patient problems: Foreign Body Reaction

  MAUDE report 21620100 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH PARKINSON'S DISEASE EXPERIENCED POSTOPERATIVE COMPLICATIONS FOLLOWING THE IMPLANTATION OF THE IM PLANTABLE NEUROSTIMULATOR. THE PATIENT EXHIBITED SIGNS OF REJECTION, ULCERATION, AND EXPOSURE OF THE LEAD AT THE SITE OF THE LEAD IMPLANT IN THE HEAD, ALONG WITH REDNESS, SWELLING, AND PUS OOZING FROM THE SITE. INTERMITTENT PUS AND SCAB FORMATION WERE ALSO NOTED. ADDITIONALLY, THERE WAS EXPOSURE OF THE EXTENSION IMPLANTED BEHIND THE EAR. THE PATIENT RETURNED TO THE HOSPITAL FOR DEBRIDEMENT, BUT THE SYMPTOMS PERSISTED. THE DOCTOR SUGGESTED THE POSSIBILITY OF DEVICE REMOVAL DUE TO THE PATIENT'S REJECTION CONSTITUTION, BUT THE PATIENT CONTINUED TO USE THE DEVICE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Erosion; Erythema; Foreign Body Reaction; Purulent Discharge; Scar Tissue; Swelling/ Edema; Ulcer

  MAUDE report 21504183 ↗
• MalfunctionOct 21, 2024Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED THAT THEIR CONCERN ABOUT POTENTIAL ISSUES WITH EXTERNAL EQUIPMENT IN THE FUTURE BECAUSE PT RECHARGES EVERY DAY AND IT HAS NOW BEEN 3 DAYS DUE TO IT WAS OVER A WEEKEND, THEY HAVEN'T GOTTEN ANY SLEEP FOR 2 NIGHTS. CALLER REVIEWED A TIME IN THE PAST WHEN PT HAD THE RECHARGER REPLACED AND ANOTHER TIME WHEN PT HAD A DIFFICULT TIME RECHARGING, THE BATTERY WENT 3 DAYS AND IT WOULD NOT CHARGE, THEY CONTACTED THE REP TO RESOLVE THE RECHARGING ISSUE. THEY REVIEWED THE WIRELESS TRANSITION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490540 ↗
• MalfunctionSep 18, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED STATING IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Burning Sensation; Insufficient Information

  MAUDE report 20246039 ↗
• MalfunctionSep 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CALLER HAD A BROKEN DESKTOP CHARGER. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. CALLER SAID THE PATIENT CHARGES EVERY 5-6 DAYS AND NEEDS TO RECEIVE THE REPLACEMENT TO RECHARGE, SOONER THAN MONDAY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197871 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TIC DISORDER AND THEIR IMPROVEMENT WAS NOT OBVIOUS AFTER THEIR SURGERY, AS WELL AS SERIOUS IN SOMNIA. IN 2022 THEY HAD A COMPLETE EQUIPMENT EXPLANT AND THE ISSUE WAS SAID TO BE RESOLVED.

  Patient problems: Sleep Dysfunction; Tics/Tremor

  MAUDE report 20017871 ↗

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.