ACTIVA PC 37601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,625 adverse event reports that list this exact device (DI 00643169529786), received between Nov 9, 2016 and Jul 10, 2026 — classified as 15 deaths, 710 injuries, 900 malfunctions.

The most frequently reported specific device problem is “High impedance” (261 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 1,625 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WHOLE SYSTEM OF DBS WAS EXPLANTED 2018 DUE TO INFECTION. FURTHER RESEARCH REQUIRED FOR DATE OF EXPLANT. EXACT DATE OF EXPLANT REMAINS UNKNOWN. RESOLUTION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25781830 ↗
• MalfunctionJun 22, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT HAD THEIR FIRST SURGERY IN 2016. HIGH IMPEDANCE WAS FIRST NOTED ON CONTACT 0 IN 2017. MULTIPLE ABNORMAL IMPEDANCES WERE NOTED ON CONTACTS 8, 9, AND 11 BEFORE ON (B)(6) 2022 SURGERY. THE LAST NOTE SHOWS HIGH IMPEDANCE ON LEFT LEAD CONTACT 0 - >5K MONOPOLAR AND >10K BIPOLAR AND RIGHT LEAD CONTACTS 11 (2994), 9 (2767), AND 8 (3661) MONOPOLAR AND BIPOLAR. THE ETIOLOGY WAS POSSIBLY RELATED TO THE DEVICE/THERAPY - LEADS). THE CONTACTS HAVE BEEN AVOIDED; NO ACTIONS TAKEN. THE ISSUE IS UNRESOLVED WITH NO FURTHER ACTION PLANNED. THERE WERE NO PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25582475 ↗
• MalfunctionMay 18, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT ROUTINE ERI BATTERY CHANGE FOR RIGHT IMPLANT TODAY, RECEIVED NOTES FROM NURSE THAT WERE UNCLEAR AS TO WHEN PATIENT SEEN LAST BY FELLOWS AND DOCUMENTATION ABOUT LEADS. UNCLEAR IF RIGHT LEAD INTO THIS IMPLANT IS CUT OR JUST NOT PROGRAMMED OR FOR WHAT REASON. TOLD LEFT CHEST HAS IMPLANT THAT IS NOT TO HAVE IMPEDANCES CHECKED ON BECAUSE THAT LEAD HAS BEEN CUT UP NEAR BHD AND IMPEDANCE TEST CAUSES DISCOMFORT SENSATION. ASKED FOR MORE DETAILS BUT NURSE DID NOT KNOW THE DETAILS AS IT WAS A FORMER FELLOW WHO MANAGED THE PATIENT AND NO ADDITIONAL DETAILS IN NOTES. NO FURTHER ACTION IS PLANNED AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 25202535 ↗
• InjuryMar 30, 2026Battery Problem

  IT WAS REPORTED THAT PATIENT (PT) IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED BECAUSE, IT KEPT LOSING IT'S POWER. NO FURTHER I NFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717046 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REP MENTIONED HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED 3 TIMES AND HAVING CORDS REPLACED BEFORE. DID NOT ASK FURTHER DETAILS DUE TO NATURE OF CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028240 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REP GOT A TEXT FROM THE MANAGING DOCTOR AND THE DOCTOR MENTIONED THE PATIENT (PT) HAD A "SEIZURE" YEARS AGO WHEN THEIR BATTERY DIED.

  Patient problems: Convulsion/Seizure

  MAUDE report 23770275 ↗
• MalfunctionNov 24, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS PROVIDED, INDICATING THAT THE CAUSE OF THE IMPEDANCE ISSUE REMAINS UNKNOWN. THE POCKET ADAPTER WAS REPLACED, BUT THE ISSUE PERSISTED, AND THE PATIENT IS UNSURE WHEN OR HOW IT OCCURRED. DOCTORS HAVE SUBMITTED A REFERRAL TO NEUROLOGY SO THE PATIENT CAN BE SEEN AND FOLLOWED, AS THE PATIENT IS CURRENTLY NOT UNDER ONGOING CARE. THE ISSUE HAS NOT BEEN RESOLVED, AND THIS INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632659 ↗
• InjurySep 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE PATIENT MENTIONED THE FIRST PRIMARY CELL THEY HAD WAS SUPPOSED TO LAST 5 YEARS AND IT ONLY LASTED 3 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075666 ↗
• MalfunctionJul 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) REACHED END OF SERVICE (EOS), AND HIGH THERAPY IMPEDANCE WAS OBSERVED. ELECTRODE IMPEDANCE TESTING AT 0.5V AND 0.7V REVEALED ALL ELECTRODE IMPEDANCES WERE IN THE 3000 OHMS RANGE, WITH THE USED BIPOLAR GROUP AT 3505 OHMS. THE PATIENT WAS PROGRAMMED ON 0- AND 3+ AT 0.5V, 70 MICROSECONDS, AND 130 HZ. IT WAS NOTED THAT HIGH IMPEDANCES HAD BEEN PREVIOUSLY OBSERVED DURING A PRIOR VISIT, BUT THE ONSET WAS UNCLEAR. THE DEVICE WAS REPLACED DUE TO EOS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568919 ↗
• MalfunctionMay 13, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) WHO REPORTED THEY ATTEMPTED TO INTERROGATE THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) TODAY WITH TWO DIFFERENT TABLETS AND GOT THE SAME SYSTEM ERROR 0X4B81F1A3 AND THE ONLY OPTION WAS TO RESTART. WHEN THEY DID, THEY GOT THE SAME MESSAGE WHEN RE-INTERROGATING. IT WAS NOTED THEY HAVE UPDATED THE TABLETS WITH RECENT SENSIGHT UPDATE. IT WAS NOT CONFIRMED THAT THE PATIENT PROGRAMMER (PP) COULD INTERROGATE AFTER THE HCP GOT THESE MESSAGES, THOUGH THEY DID NOTE THE PATIENT HAD BEEN ABLE TO RECENTLY INTERROGATE THE INS WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011241 ↗
• InjuryMay 1, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DECIDED THEY DID NOT WANT DEEP BRAIN STIMULATION AND REQUESTED THE REMOVAL OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS. THE LEADS WERE CAPPED WITH BOOTS INSTEAD OF THE CORRECT END CAPS DUE TO SHORT NOTICE AND UNAVAILABILITY. THIS IMPACTED FUTURE MAGNETIC RESONANCE IMAGING (MRI) ELIGIBILITY UNLESS THE ENTIRE SYSTEM IS REMOVED OR CORRECT END CAPS ARE APPLIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943324 ↗
• MalfunctionFeb 4, 2025Failure to Deliver Energy; Insufficient Device Problem Information; Failure to Deliver Energy; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. THE CAUSE OF THE DEVICE NOT WORKING WAS DUE TO THE IMPLANTABLE NEU ROSTIMULATOR (INS) BEING OFF. THE DEVICE WAS TURNED BACK ON AND THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303207 ↗
• MalfunctionNov 14, 2024Low impedance; Battery Problem; Low impedance; Battery Problem

  IT WAS REPORTED THAT PATIENT SAW ERI (ELECTIVE REPLACEMENT INTERVAL) ON THEIR PATIENT PROGRAMMER. AGENT REVIEWED MEANING. PATIENT MENTIONED SEEING A NEUROSURGEON ABOUT TWO YEARS AGO BECAUSE THERE WAS A SHORT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683706 ↗
• MalfunctionOct 29, 2024Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  PROVIDER REPORTS PATIENT WAS HAVING THEIR PACEMAKER CHECKED AND WHILE DOING SO, THE TELEMETRY WAND PASSED OVER THE PATIENT TO GET TO THE OTHER SIDE, AND THE PATIENT REPORTED A SHOCKING SENSATION FROM THEIR DBS (DEEP BRAIN STIMULATION) SYSTEM. PROVIDER WAS NO LONGER WITH THE PATIENT, BUT STATED THE PATIENT FELT FINE BEFORE THEY LEFT.

  Patient problems: Electric Shock

  MAUDE report 20557185 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THEY A NON-RECHARGEABLE BATTERY THAT GOT INFECTED, AND THEY ALMOST DIED. THE B ATTERY WAS REPLACED WITH A NON-RECHARGEABLE ONE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 20458363 ↗
• MalfunctionAug 13, 2024Impedance Problem; Impedance Problem

  THERE AREN¿T ANY ISSUES WITH THIS PATIENT¿S IMPEDANCES. MDT REP JUST SAW THIS PATIENT ON AUGUST 19TH AND THEIR IMPEDANCES WERE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972343 ↗
• MalfunctionJul 19, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE IMPEDANCE VALUES FOR ALL PAIRS WITH SEGMENT 1B WERE >5000 OHMS. ALL OTHER IMPEDANCE VALUES "LOOK GREAT". THE PATIENT HAS EXPERIENCED A MILD LOSS OF THERAPY BUT THEY WANT TO WAIT TO DO A SURGICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 19784481 ↗
• InjuryJul 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN IMPLANT REPLACEMENT ON 6-28-2019. NO FURTHER INFO PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658829 ↗
• MalfunctionJun 26, 2024Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Data Problem; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Data Problem

  IT WAS REPORTED THAT ABOUT 6 MONTHS AGO THE PATIENT'S THERAPY SETTINGS "ALL THE SUDDEN WENT TO 10 BY ITSELF" AND THE PATIENT FELT SHOCKS IN THEIR HEAD. THE PATIENT ALSO MENTIONED THAT THEY WERE SEEING THE ERI SCREEN ON THEIR PATIENT PROGRAMMER. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED THAT THEY HAVE ESSENTIAL TREMOR THAT THEY STATE  KIND OF PROGRESSED TO EARLY STAGE PARKINSON'S.

  Patient problems: Electric Shock

  MAUDE report 19615868 ↗
• MalfunctionMay 6, 2024Failure to Power Up; Insufficient Device Problem Information; Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT DROPPED THEIR PATIENT PROGRAMMER IN THE TOILET AND NOW IT WILL NOT TURN ON, EVEN WITH NEW AAA BATTERIES. THE PROGRAMMER WAS ALSO DISPLAYING A MESSAGE THAT SAID "TO CALL SOMEONE", BUT PATIENT DOESN'T REMEMBER THE MESSAGE. PROVIDER SAID PATIENT'S THERAPY IS AFFECTED SINCE PATIENT DOESN'T HAVE EXTERNAL EQUIPMENT TO ADJUST THERAPY. PATIENT SERVICES EMAILED REPAIR TO SEND REPLACEMENT PATIENT PROGRAMMER. (B)(6) 2024 LFC (HCP): NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19248340 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED FROM THE PATIENT'S CHEST BECAUSE IT GOT INFECTED, AND THE REPLACEMENT INS WAS IMPLANTED IN THE PATIENT'S ABDOMEN. THE CALLER STATED THAT THE PATIENT WAS IN REHAB FOR 97 DAYS.

  Patient problems: Unspecified Infection

  MAUDE report 19182684 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) WHO REPORTED THE INS WAS REMOVED FOR AN INFECTION ALONG WITH THE LEAD AND EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 19048945 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEE A. T., HAN K. J., NICHOLS N., SUDHAKER V. R., BURKE J. F., WOZNY T. A., CHUNG J. E., VOLZ M. M., OSTREM J. L., MARTIN A. J., LARSON P. S., STARR P. A., WANG D. D. TARGETING ACCURACY AND CLINICAL OUTCOMES OF AWAKE VERSUS ASLEEP INTERVENTIONAL MAGNETIC RESONANCE IMAGING-GUIDED DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: THE UNIVERSITY OF CALIFORNIA, SAN FRANC NEUROSURGERY 2022 DOI: 10.12 27/NEU.0000000000002111 ABSTRACT: BACKGROUND: INTERVENTIONAL MRI (IMRI)-GUIDED IMPLANTATION OF DEEP BRAIN STIMULATOR (DBS) LEADS HAS BEEN DEVELOPED TO TREAT PATIENTS WITH PARKINSON¿S DISEASE (PD) WITHOUT THE NEED FOR AWAKE TESTING. OBJECTIVE: DIRECT COMPARISONS OF TARGETING ACCURACY AND CLINICAL OUTCOMES FOR AWAKE STEREOTACTIC WITH ASLEEP IMRI-DBS FOR PD ARE LIMITED. METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF PATIENTS WITH PD WHO UNDERWENT AWAKE OR IMRI-GUIDED DBS SURGERY TARGETING THE SUBTHALAMIC NUCLEUS OR GLOBUS PALLIDUS INTERNA BETWEEN 2013 AND 2019 AT OUR INSTITUTION. OUTCOME MEASURES INCLUDED UNIFIED PARKINSON¿S DISEASE RATING SCALE PART III SCORES, LEVODOPA EQUIVALENT DAILY DOSE, RADIAL ERROR BETWEEN INTENDED AND ACTUAL LEAD LOCATIONS, STIMULATION PARAMETERS, AND COMPLICATIONS. RE

  Patient problems: Unspecified Infection

  MAUDE report 19047623 ↗
• MalfunctionMar 13, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED NEUROSTIMULATOR (INS). THE PATIENT REPORTED THAT THE INS DID NOT LAST AS LONG AS THEY EXPECTED IT TO. THE PATIENT STATED THAT THEY "HAD TO GO ABOUT A WEEK WITHOUT THE BATTERY" BECAUSE THE INS BATTERY DEPLETED SOONER THAN EXPECTED. THE PATIENT NOTED THAT THEY "MAY HAVE BEEN A HEAVY USER." NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897166 ↗
• MalfunctionMar 1, 2024Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THEY WERE PREPARING FOR INS REPLACEMENT FROM PATIENT'S EXISTING ACTIVA PC TO PERCEPT RC AND UPON ATTEMPTING TO TRANSFER SETTINGS, ONCE IT SHOWS "COMMUNICATION IN PROGRESS", IT GIVES A TELEMETRY FAILURE WITH CODE 67B670A5 WITH OPTION TO END SESSION. CALLER HAS TRIED THREE TIMES AND HAS HAD THE SAME RESULT EACH TIME. CALLER STATED THAT PATIENT HAS GROUP A THAT IS ACTIVE, PROGRAMMED TO BIPOLAR AT LOW AMPLITUDE WITH 60 PW, 130 RATE. CALLER STATED PATIENT ALSO HAS GROUP B THAT IS INTERLEAVED. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECH SERVICES (TSS)  REVIEWED INPUTTING THE SETTINGS MANUALLY AND WOULD SEND AND EMAIL WITH ADDITIONAL INFORMATION TO COLLECT LOG FILES. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816669 ↗

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-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.