Activa® 37603Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,093 adverse event reports that list this exact device (DI 00613994761071), received between Apr 26, 2013 and Oct 15, 2025 — classified as 8 deaths, 512 injuries, 573 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (200 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 25 most recent of 1,093 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT MENTIONED WHEN ADJUSTING THERAPY , FEELING A SHOCK RIGHT AFTER IMPLANT IN 2016. PATIENT ALSO MENTIONED THEY USE TO HAVE EXTREME TREMORS.

  Patient problems: Electric Shock; Shaking/Tremors

  MAUDE report 23301090 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT'S IMPLANT WAS REMOVED MULTIPLE YEARS AGO BECAUSE IT BECAME INFECTED AND THE PATIENT NEVER ELECTED TO HAVE IT REPLACED. THE CALLER STATED THEY PROBABLY DIDN'T EVEN HAVE THE DEVICE FOR 6 MONTHS WHEN THE INFECTION OCCURRED.

  Patient problems: Unspecified Infection

  MAUDE report 22728788 ↗
• InjuryJul 24, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT ELECTRODE ZERO WAS FLUCTUATING BETWEEN LOW AND HIGH IMPEDANCE. NO KNOWN ENVIRONMENTAL OR EXTERNAL FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE ISSUE. DIAGNOSTICS INCLUDED REPLACING THE EXTENSION, WHICH DID NOT RESOLVE THE PROBLEM, AND TESTING THE LEAD, WHICH SHOWED THE SAME IMPEDANCE FLUCTUATION. THE PATIENT WAS REPROGRAMMED TO ANOTHER CONTACT WITH NORMAL IMPEDANCE, RESOLVING THE ISSUE. SURGICAL INTERVENTION OCCURRED, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATING THAT THE PATIENT'S IPG'S WERE REPLACED DUE TO NORMAL END OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591349 ↗
• MalfunctionMay 14, 2025Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS DEAD AND COULD NOT BE INTERROGATED WITH EITHER THE CLINICIAN TABLET OR HANDSET. THE CALLER MENTIONED THAT THE PATIENT TURNED THEIR THERAPY OFF 8 YEARS AGO AND DOES NOT CURRENTLY HAVE A PHYSICIAN THEY FOLLOW. THE CALLER WAS UNCERTAIN ABOUT WHEN THIS ISSUE BEGAN. NO SYMPTOMS/COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6), CONFIRMING THAT THE PATIENT DECIDED TO TURN THE BATTERY OFF AND NO ACTIONS WERE TAKEN DUE TO THE PATIENT'S DECISION. THE INFORMATION WAS CONFIRMED WITH THE HEALTHCARE PROVIDER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023264 ↗
• InjuryMar 20, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM PATIENT. PATIENT REPORTED THAT THAT SWITCHING TO A RECHARGEABLE NEUROSTIMULATOR RESOLVED ISSUE OF BATTERIES GOING TOO QUICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658814 ↗
• MalfunctionDec 4, 2024Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS NOT WORKING FOR ALMOST 7 YEARS, FAILING TO ALLEVIATE THE PATIENT'S TREMORS. THE PATIENT EXPERIENCED SIDE EFFECTS, INCLUDING TWITCHING IN THE FACE AND AFFECTED THE MOUTH'S RIGHT SIDE. ADDITIONALLY, FOR THE PAST 8-9 MONTHS OR LONGER, THEY HAVE OCCASIONALLY FELT A TWINGE OF A SHOCK WHEN LYING DOWN ON THE LEFT SIDE, WHERE THE IMPLANT IS LOCATED. WHEN ASKED, PATIENT SAID HAS VERTIGO AND FALLS A LOT. THEY WERE ADVISED TO CONSULT THEIR HEALTHCARE PROVIDER AND TO SCHEDULE AN APPOINTMENT TO HAVE THE IMPLANTED SYSTEM CHECKED. PATIENT STATED THE SYSTEM HASN'T EVER BEEN CHECKED OTHER THAN DURING REPROGRAMMING APPOINTMENTS. WHEN OFFERED TO CHECK LISTINGS, PATIENT DECLINED.

  Patient problems: Electric Shock; Shaking/Tremors; Twitching; Vertigo

  MAUDE report 20844832 ↗
• MalfunctionOct 21, 2024Material Frayed; Connection Problem; Material Integrity Problem; Material Frayed; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FRAYED DESKTOP CHARGER CORD/BROKEN CONNECTOR PIN. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE FRAYED CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490633 ↗
• InjurySep 24, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LEAD EXPLANT AS PATIENT NOW HAS NEW ABBOTT LEADS PLACED IN NEW TARGET. WAS TOLD THAT MEDTRONIC TARGET WAS NOT EFFICACIOUS.

  Patient problems: Insufficient Information

  MAUDE report 20292628 ↗
• MalfunctionMay 8, 2024Failure to Deliver Energy; Failure to Deliver Energy

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THERAPY BEING OFF WAS THEM INADVERTENTLY TURNING OFF THE DEVICE WHILE STARTING IT. THE PATIENT WAS GIVEN INSTRUCTIONS ON HOW TO USE THE DEVICE. THE ISSUE WAS RESOLVED.

  Patient problems: Shaking/Tremors

  MAUDE report 19268410 ↗
• MalfunctionApr 18, 2024Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE CONNECTION ISSUE WASN¿T DETERMINED. A PATIENT PROGRAMMER WAS USED TO TURN THE IMPLANT OFF. IF THE ISSUE PERSISTED THEY WERE GOING TO USE A METAL BARRIER OVER THE PATIENT¿S PERCEPT DEVICE TO PREVENT THE DBS APP FROM FINDING THAT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135528 ↗
• InjuryApr 5, 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 19051726 ↗
• InjuryApr 5, 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: Intracranial Hemorrhage

  MAUDE report 19049368 ↗
• 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: Hematoma

  MAUDE report 19047878 ↗
• 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 19047840 ↗
• 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 FRANCISCO 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 COMPLICATIO

  Patient problems: Unspecified Infection

  MAUDE report 19047778 ↗
• MalfunctionMar 28, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Impedance Problem; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THAT SINCE (B)(6) 2023 THEY HAD BEEN EXPERIENCING A DISCOMFORT ("ELECTRICAL SENSATIONS", "POWER SURGES", "ELECTRICAL PULLS", "LEGS KILLING THEM FROM VOLTAGE DISCHARGES WHEN AROUND EQUIPMENT WITH BATTERIES IN IT") WHEN THEY WERE AROUND CERTAIN PIECES OF EQUIPMENT THAT HAD A BATTERY IN IT (ELECTRIC WHEEL CHAIR, COMPUTER, CELL PHONE, ECT). PT SAID THAT THESE SENSATIONS WOULD CONTINUE AROUND THE EQUIPMENT EVEN IF THEIR DBS WAS TURNED OFF AND THIS MADE THEM WANT TO HAVE THE DBS SYSTEM REMOVED. PT SAID WHEN THEY INCREASED DISTANCE FROM THE EQUIPMENT THE SENSATIONS WENT AWAY). PATIENT SAID THEY HAD TO PUT THEIR ELECTRIC WHEELCHAIR OUT OF THE HOUSE BECAUSE IT WAS MAKING THEM SICK. THE PATIENT SAID THEY HAVE PARKINSON'S DISEASE SO THEY HAD FALLEN MORE THAN ONCE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT MENTIONED THEY HAD LET THEIR MANAGING HCP KNOW ABOUT THE ISSUE BUT THE DR. TOLD THEM THINGS LIKE THIS WEREN'T ABLE TO HAPPEN.

  Patient problems: Discomfort; Electric Shock

  MAUDE report 18996269 ↗
• MalfunctionMar 15, 2024Malposition of Device; Battery Problem; Malposition of Device; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE IMPROPER LEAD PLACEMENT WASN¿T DETERMINED AND NO FURTHER INFORMATION WAS AVAILABLE AS THE PHYSICIAN WAS NO LONGER AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18917417 ↗
• MalfunctionMar 4, 2024Charging Problem; Connection Problem; Charging Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DAMAGED DESKTOP CHARGER (DTC) CORD. THE DTC WAS DAMAGED "ABOUT A MONTH AGO." THEN, "ABOUT SATURDAY," THEY NOTICED THE RECHARGER DID NOT SEEM TO TAKE A CHARGE FROM THE DTC UNLESS THEY JIGGLED THE DTC. ON THAT SAME DAY, THE CALLER ALSO NOTICED THAT THE DTC CONNECTOR PIN SEEMED LOOSE. DURING THE CALL, THE CALLER NOTED THAT THE DTC CONNECTOR PIN DID NOT SEEM TO BE AS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831403 ↗
• MalfunctionFeb 21, 2024Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DESKTOP CHARGER (DTC) CONNECTOR PIN IS WIGGLY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751219 ↗
• MalfunctionFeb 12, 2024Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED BY MDT REP THAT PATIENT IS HAVING TINGLING SENSATION ON HIS RIGHT EAR DOWN TO HIS NECK. REP REPORTS PATIENT INDICATED WHEN HE TURNS HIS STIMULATION OFF, THE TINGLING SENSATION GOES AWAY. REP REPORTS THE TINGLING SENSATION IS ON PATIENT'S LEFT LEAD AND RIGHT IMPLANTABLE NEUROSTIMULATOR (INS).

  Patient problems: Paresthesia; Undesired Nerve Stimulation

  MAUDE report 18691280 ↗
• MalfunctionFeb 1, 2024Display or Visual Feedback Problem; Failure to Power Up; Charging Problem; Display or Visual Feedback Problem; Failure to Power Up; Charging Problem

  IT WAS REPORTED THAT THE WIRELESS RECHARGER (WR) WAS OOB. THE WR WON'T POWER UP. RESETTING THE WR DIDN'T RESOLVE THE ISSUE. IT WAS CONFIRMED THE DOCK HAD POWER AND THE DEVICE WON'T RECHARGE WHILE ON THE DOCK, NO BATTERY INDICTOR LIGHT. THE ISSUE WAS NOT RESOLVED DURING TROUBLESHOOT. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622730 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WON'T POWER ON WITH NEW BATTERIES. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608280 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT SHE TRIED TO TURN THE PROGRAMMER ON BUT IT WOULD NOT RESPOND. CALLER TRIED 'MEDCELL PROFESSIONAL' BATTERIES WHICH SHE STATED WERE NEW. THE CALLER ALSO TRIED REGULAR ALKALINE BATTERIES. CALLER STATED THE BATTERIES WERE PLACED IN THE PROGRAMMER CORRECTLY. THE CALLER STATED THEY WERE NOT AWARE OF PRODUCT BEING DROPPED OR WET. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE PROGRAMMER. 2021-OCT-26 (B)(4) (HCP): THE HEALTHCARE PROVIDER (HCP) CALLED BACK AND INQUIRED HOW TO USE THE PATIENT PROGRAMMER (PP). TECHNICAL SERVICES (TS) REVIEWED HOW TO SYNC. UPON HAVING CALLER TEST TO SEE IF DEVICE TURNED ON, IT APPEARS THAT BATTERIES SHE USED FROM PRIMARY CALL WERE DEPLETED. AFTER GRABBING A DIFFERENT SET, PP TURNED ON AND FUNCTIONED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606453 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT SHE TRIED TO TURN THE PROGRAMMER ON BUT IT WOULD NOT RESPOND. CALLER TRIED 'MEDCELL PROFESSIONAL' BATTERIES WHICH SHE STATED WERE NEW. THE CALLER ALSO TRIED REGULAR ALKALINE BATTERIES. CALLER STATED THE BATTERIES WERE PLACED IN THE PROGRAMMER CORRECTLY. THE CALLER STATED THEY WERE NOT AWARE OF PRODUCT BEING DROPPED OR WET. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE PROGRAMMER. (B)(6) 2021, RTG0228912 (HCP): THE HEALTHCARE PROVIDER (HCP) CALLED BACK AND INQUIRED HOW TO USE THE PATIENT PROGRAMMER (PP). TECHNICAL SERVICES (TS) REVIEWED HOW TO SYNC. UPON HAVING CALLER TEST TO SEE IF DEVICE TURNED ON, IT APPEARS THAT BATTERIES SHE USED FROM PRIMARY CALL WERE DEPLETED. AFTER GRABBING A DIFFERENT SET, PP TURNED ON AND FUNCTIONED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606440 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Energy Output Problem; Failure to Power Up; Insufficient Device Problem Information; Display or Visual Feedback Problem; Energy Output Problem; Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) SHOWED A 'CALL YOUR DR.' MESSAGE AND STATED THAT THE CALL YOUR DR. MESSAGE CLEARED AWAY. THEN THE PP SCREEN WENT BLANK AND WOULDN'T POWER ON WITH 2 SETS OF NEW BATTERIES. THE PATIENT STATED THAT HE TURNS STIMULATION UP TO DRIVE AND SAID WHEN STIMULATION IS TURNED UP HE CAN'T TALK. SINCE THE PP DOESN'T POWER ON, HE WASN'T ABLE TO ADJUST STIMULATION CURRENTLY; THEREFORE, HE WAS "STUCK" AT HOME NOT BEING ABLE TO DRIVE UNTIL THE REPLACEMENT PATIENT PROGRAMMER ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606248 ↗

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-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.