Activa® PC 37601 (UDI 00763000384326)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000384326), received between Jul 29, 2021 and Jul 11, 2025 — classified as 14 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Low impedance” (5 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, H050003, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION PATIENT EXPERIENCED A SHORT CIRCUIT INVOLVING THE ACTIVA PC IMPLANTABLE NEUROSTIMULATOR AND AN EXTENSION. THE PATIENT WAS TREATED BY REPLACEMENT OF BOTH THE STIMULATOR AND THE EXTENSION, AND THE SHORT RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480029 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROVIDER THAT THE PATIENT'S ENTIRE DBS SYSTEM WAS REMOVED ON (B)(6) 2024, DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21219832 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE PRODUCT WAS REPORTED TO BE FULLY IMPLANTED FROM THE HEALTHCARE PROVIDER.

  Patient problems: Extravasation; Unspecified Infection

  MAUDE report 20865045 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SKIN OF THE IMPLANT SITE WAS BROKEN AND THE STIMULATOR WAS EXPOSED. THEY CONTACTED THE DOCTOR FOR TREATMENT AND THE MINOR INFECTION HAD BEEN TREATED IN THE LOCAL HOSPITAL. THE ISSUE WAS RESOLVED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 20557689 ↗
• InjuryOct 15, 2024Inappropriate/Inadequate Shock/Stimulation; Material Deformation; Inappropriate/Inadequate Shock/Stimulation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM THEMANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE EXTENSION LOOP THAT WAS FELT UNDER THE SKIN WAS ON THE LEFT (LATERAL) SIDE OF THE IMPLANT.

  Patient problems: Electric Shock

  MAUDE report 20448054 ↗
• MalfunctionSep 27, 2024Break; Low impedance; Break; Low impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED IT WAS UNKNOWN WHAT LED TO THE FRAYED EXTENSION. THERE WERE NO ACTIONS PLANNED TO RESOLVE THE ISSUE, BUT RATHER THE HCP PROGRAMMED AROUND IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318190 ↗
• MalfunctionMay 24, 2023Failure to Deliver Energy; Communication or Transmission Problem; Insufficient Device Problem Information; Data Problem; Failure to Deliver Energy; Communication or Transmission Problem; Insufficient Device Problem Information; Data Problem

  IT WAS REPORTED THAT THE PATIENT JUST GOT A BATTERY REPLACEMENT AND WAS PROGRAMMED WITH THE NEW DBS CLINICIAN TABLET. THE PATIENT WENT TO THE DOCTOR FOR CONTROL AND THE DOCTOR INTERROGATED THE DBS USING THE OLD CLINICIAN PROGRAMMER (N'VISION). STIMULATION WAS OFF SO THE SYMPTOM APPEARED. ONCE CHECKED WITH THE PATIENT PROGRAMMER (PP), ERROR 574 APPEARED. THE CAUSE OF THE ERROR 574 WAS DUE TO THE DOCTOR INTERROGATING WITH THE CLINICIAN PROGRAMMER/N'VISION. USING THE DBS CLINICIAN TABLET SHOWED A FEW ERROR MESSAGES/ALERTS INCLUDING: LOW COMMUNICATOR BATTERY, END SESSION: THE ACTIVE GROUP HAS NO VALID PROGRAMS. STIMULATION IS OFF., AND NEUROSTIMULATOR STATUS: NO ACTIVE GROUP. STIMULATION CANNOT BE TURNED ON. THE ISSUE WAS RESOLVED AFTER USING THE DBS CLINICIAN TABLET TO INTERROGATE THE PATIENT, REPROGRAMMING SESSION (FULFIL THE DATA AND PUT THE EXISTING PROGRAM), AND THEN TURN ON THE STIMULATION. AFTER STIMULATION ON, THE SYMPTOM OF DISEASE WAS GONE AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THEY WILL CONTINUE TO USE THE DBS CLINICIAN TABLET FOR NEXT PROGRAMMING SESSION.

  Patient problems: Insufficient Information

  MAUDE report 17000150 ↗
• InjuryFeb 14, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAD LOW IMPEDANCES ON ALL BIPOLAR CONTACT COMBINATIONS FOR THE RIGHT STN AND THE SAME IMPEDANCES VALUES FOR THE MONOPOLAR IMPEDANCE VALUES IN THE RIGHT STN. THE IMPEDANCES VALUES FOR THE LEFT STN WERE ALL IN RANGE. THE CAUSE WAS UNKNOWN AND SURGICAL INTERVENTION WAS PLANNED. THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372375 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS RED AND SWOLLEN AFTER SURGERY. IT WAS DIAGNOSED AS INFECTED. THE SURGEON REMOVED THE BATTERY FROM THE PATIENT'S INS POCKET AND REPEATED DISINFECTION AND CLEANING. AFTER ONE MONTH, THE PATIENT BECAME INFLAMED AND INFECTED AGAIN. SINCE THE ORIGINAL INS BATTERY HAD BEEN SOAKED IN CONCENTRATED WATER, THE DOCTOR ADVISED THE PATIENT TO REPLACE IT WITH A NEW BATTERY. THE PATIENT IS CURRENTLY UNDER OBSERVATION IN THE HOSPITAL.

  Patient problems: Erythema; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 15770419 ↗
• InjurySep 30, 2022Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SHOCKING SENSATIONS SATURDAY BEFORE REMOVAL. CIRCUMSTANCES THAT MAY HAVE LED TO THE ISSUE WERE UNKNOWN. IMPEDANCES WERE TESTED SEVERAL TIMES AND WERE LOW. EXTENSIONS WERE DISCONNECTED AND RECONNECTED AND FINALLY, AN EXTENSION WAS REPLACED. THE ISSUE WAS RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 15519021 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AFTER SURGERY FOR A BATTERY REPLACEMENT IN (B)(6) 2021, THE SITE WHERE THE BATTERY WAS IMPLANTED BECAME INFECTED, AND THE WOUND SITE WAS RED, SWOLLEN AND PAINFUL. THE BATTERY WAS EXPOSED IN (B)(6) LAST YEAR. A SECOND SURGERY WAS PERFORMED ON (B)(6). AFTER ADJUSTING THE IMPLANTATION POSITION OF THE BATTERY TO THE ARMPIT, THE INFECTION OCCURRED AGAIN. THE THIRD SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE POSITION OF THE BATTERY WAS ADJUSTED FROM THE ARMPIT TO THE CLAVICLE ON THE RIGHT CHEST, BUT IT STILL WAS IN A STATE OF INFECTION. AT PRESENT, THE BATTERY IS ABOUT TO BE EXPOSED AGAIN. THE PATIENT CONTACTED THE DOCTOR. THE DOCTOR SAID THAT THE BATTERY SHOULD BE REMOVED FIRST AND THEN RE-IMPLANTED AFTER 3-6 MONTHS. THE PATIENT IS CURRENTLY HOSPITALIZED.

  Patient problems: Erythema; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 15300877 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT PRIOR TO SURGERY ¿THE PATIENT¿S MAIN EYE COULD OPEN¿ AND THAT THEY HAD TORTICOLLIS AND THEIR HEAD WAS THROWN BACK WHILE SPEAKING AND THAT AFTER IMPLANT THE PATIENT¿S POSTOPERATIVE TORTICOLLIS HAD IMPROVED SIGNIFICANTLY. HOWEVER, ¿IN THE SECOND WEEK AFTER THE BOOT, THE EYES COULD NOT OPEN¿ AND THE PATIENT EXPERIENCED ¿PAIN AROUND THE FOREHEAD WHEN SPEAKING OR EXERTING FORCE. IF THE PATIENT¿S EYES COULD OPEN THEIR NECK WOULD SWING LEFT AND RIGHT. THE PATIENT ¿COULD NOT SPEAK CLEARLY, HAD DIFFICULTY SWALLOWING,¿ AND THEIR ¿EXPRESSION WAS RATHER UGLY.¿ THE PATIENT RETURNED TO THE HOSPITAL FOR PROGRAMMING ONCE A WEEK, BUT IT HAD NOT IMPROVED. IT WAS UNKNOWN WHETHER ANY EFFECTIVE MEASURES HAD OR WOULD BE TAKEN OR WHAT TROUBLESHOOTING WAS PERFORMED. THE PATIENT WAS AT HOME AT THE TIME OF REPORT AND WAS SEEKING A BETTER SOLUTION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. IT WAS REPORTED THAT DUE TO THE PATIENT'S POOR POST-OPERATIVE EFFECT AND PAIN AT THE INS SITE, THE INS AND EXTENSIONS WERE EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia; Dysphasia; Insufficient Information; Pain; Visual Impairment

  MAUDE report 15233099 ↗
• MalfunctionAug 15, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS DRAINING UNUSUALLY FAST. IT HAD BEEN 10 MONTHS SINCE BEING IMPLANTED AND TREATMENT WAS SET TO 1.2V, BUT THE BATTERY CAPACITY WAS 2.87V, WHICH WAS CONSIDERED ABNORMALLY FAST BY THE CLINICIAN. THE CAUSE WAS UNKNOWN, BUT BECAUSE THE PATIENT'S SYMPTOMS HAVEN'T CHANGED THERE WAS NOT MUCH TREATMENT DONE. THE ISSUE WASN'T RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15227577 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS MAIN SYMPTOMS BEFORE SURGERY WERE SHAKING AND BAD WALKING, BUT THE PATIENT COULD TAKE CARE OF THEMSELVES. AFTER THE SURGERY THE SITUATION WAS WORSE THAN BEFORE AND NOW THEIR HANDS AND LEGS WERE SHAKING AND THEY COULDN'T TAKE CARE OF THEMSELVES. THEY NEEDED HELP TO GET DRESSED, HAD POOR SLEEP, THEIR BACK HURT, AND THEY COULDN'T GO OUT AND ONLY WALKED AROUND HOME. THEY WENT BACK TO THE HOSPITAL FOR PROGRAMMING EVERY MONTH, BUT NOW LATER THEY WERE HOSPITALIZED FOR MORE THAN 10 DAYS BEFORE THE NEW YEAR. HOWEVER, THEY STILL DIDN'T HAVE EFFECT AND THE PATIENT WAS STILL AT HOME.

  Patient problems: Ambulation or Postural Difficulties; Pain; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 14829245 ↗
• MalfunctionApr 7, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD RESISTANCE WAS FOUND TO BE TOO HIGH DURING THE SURGERY. THE LEAD WAS REPLACED WITH A NEW LEAD ON THE SAME DAY TO COMPLETE THE SURGERY. THERE ISN'T ANY INFLUENCE ON THE NORMAL TREATMENT CURRENTLY. THE PATIENT WAS CURRENTLY HOSPITALIZED AND UNDER OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043233 ↗
• MalfunctionFeb 16, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE RESISTANCE OF THE LEAD WAS FOUND TO BE TOO LOW DURING THE OPERATION ON (B)(6) 2022. THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THE PATIENT WAS CURRENTLY HOSPITALIZED FOR OBSERVATION. 2022-02-11 ARED_UPDATE (FOR, REP): NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543631 ↗
• InjuryFeb 13, 2022Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Patient Device Interaction Problem; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD COMPLAINED ABOUT THE SIZE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AFTER SURGERY (B)(6) 2021. THE PHYSICIAN RECEIVED A LETTER OF DISCONTENT FROM THE PATIENT ON THE INS SIZE AND THAT IT DIDN'T SEEM TO BE WORKING AS WELL AFTER THE REPLACEMENT. IT WAS NOTICED LATER THAT IT WASN'T A PERCEPT INS BUT AN ACTIVA PC AS THEY HAD BEFORE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT: IT WAS REPORTED THAT AFTER THEIR REPLACEMENT ON (B)(6) 2021 THE INCISION HEALED WELL, BUT THE BATTERY STUCK OUT TOO FAR AND CAUSED SOME ISSUES. THEY ALSO GOT A LITTLE ELECTRIC SHOCK IF THEY MOVED THEIR ARM CERTAIN WAYS AND GOT A PAIN IN THEIR NECK AND BACK. ON (B)(6) 2021 THEY WERE ABLE TO MAKE AN APPOINTMENT WITH THE PHYSICIAN. THEY NOTICED HOW FAR IT STUCK OUT, AND THE PATIENT ALSO HAD SMALL HEAD TREMORS OCCASIONALLY. IT DIDN'T SEEM LIKE OTHER TIMES THE PATIENT HAD EXPERIENCED.

  Patient problems: Electric Shock; Pain; Shaking/Tremors; Unspecified Infection

  MAUDE report 13519441 ↗
• MalfunctionJan 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD WAS FOUND TO HAVE HIGH IMPEDANCE DURING SURGERY. IT WAS REPLACED WITH A NEW LEAD ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT IS CURRENTLY UNDER OBSERVATION AT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258493 ↗
• MalfunctionDec 29, 2021High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE ISSUE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112574 ↗
• InjurySep 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE BATTERY SITE IN THE CHEST AND AT THE EXTENSION SITE BEHIND THE EAR AFTER SURGERY. THE INS, EXTENSIONS, AND LEADS WERE EXPLANTED AND WERE NOT TO BE RE-IMPLANTED. THE PATIENT WAS OBSERVING AT HOME.

  Patient problems: Unspecified Infection

  MAUDE report 12458033 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REPORTED THAT THE DEVICE HAD NOT BEEN EXPLANTED YET, AND IT WAS NOT KNOWN WHEN THE PATIENT WOULD BE RE-IMPLANTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 12244950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, 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.