Activa® 37602Recalls & reported problems

Summary

The FDA's MAUDE database contains 777 adverse event reports that list this exact device (DI 00613994761057), received between Jan 17, 2014 and Jan 27, 2025 — classified as 6 deaths, 359 injuries, 412 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (143 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

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 777 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Migration or Expulsion of Device; Battery Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE MEDICAL DOCTOR THAT THE PATIENT EXPERIENCED A DEAD BATTERY AND LEAD DISPLACEMENT ON THE LEFT SIDE, WITH THE DISTAL PORTION OF THE LEAD NEARLY AT SKULL LEVEL, AS SHOWN BY AN X-RAY. CONSEQUENTLY, THE LEFT DBS SYSTEM WAS EXPLANTED. THE PATIENT'S RIGHT DBS SYSTEM REMAINS FUNCTIONAL. THE ENVIRONMENTAL OR EXTERNAL FACTORS CONTRIBUTING TO THE ISSUE ARE UNKNOWN. NO SPECIFIC DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED BEYOND THE X-RAY EVALUATION THAT REVEALED THE LEAD DISPLACEMENT AND DEAD BATTERY. NO FURTHER INTERVENTIONS ARE KNOWN TO HAVE BEEN TAKEN. THE ISSUE IS RESOLVED AS THE AFFECTED SYSTEM HAS BEEN EXPLANTED. FOR ADDITIONAL INFORMATION, THE HEALTHCARE PROFESSIONAL CAN BE CONTACTED DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248299 ↗
• InjuryNov 11, 2024Break; Difficult to Remove; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) SCHEDULED A REMOVAL OF DBS SYSTEM FOR THE PATIENT, DUE TO SYSTEM NOT BEING USED FOR PAST 6 YEARS FOR DYSTONIA THAT WAS NEVER RESOLVED. DURING THE PROCEDURE, THE HCP DESCRIBED BONY INGROWTH OVER THE BURR HOLE DEVICE AND DIFFICULTY REMOVING THE INITIAL LEAD. AFTER SOME TIME, THE LEAD WAS REMOVED AND HCP DESCRIBED ONLY SEEING 3 ELECTRODES PRESENT ON THE REMOVED LEAD. HE THEN LEFT THE OPERATING ROOM TO SPEAK WITH THE PATIENTS HUSBAND AND EXPRESS HIS CONCERNS ABOUT ATTEMPTING TO REMOVE THE SECOND LEAD. THE HCP HAD DIFFICULTLY REMOVING LEAD DUE TO TISSUE INGROWTH, UPON REMOVING LEAD, LAST ELECTRODE APPEARED TO HAVE BEEN STRIPPED FROM LEAD AND REMAINED IN THE BRAIN. THE HUSBAND DETAILED THAT HIS WIFE¿S MAIN DISCOMFORT WAS WITH THE IMPLANTABLE NEUROSTIMULATORS (INS) AND EXTENSIONS AND TO JUST REMOVE THOSE. HCP PROCEEDED TO REMOVE THE PATIENTS BILATERAL INS AND EXTENSIONS. HCP ALSO STATED THAT THE PATIENT EXPRESSED CONCERNS IN 2016 REGARDING IMPEDANCES ON A CONTACT, AS DESCRIBED BY HER MANAGING PH YSICIAN AND WONDERED IF THEY HAD CONTRIBUTED TO HEADACHES AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE DATE OF REM

  Patient problems: Brain Injury; Device Embedded In Tissue or Plaque; Discomfort; Headache; Insufficient Information

  MAUDE report 20651672 ↗
• MalfunctionJul 15, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE SHOCKING WASN¿T DETERMINED.

  Patient problems: Electric Shock

  MAUDE report 19746736 ↗
• MalfunctionJul 15, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED TWO "MAJOR SHOCKS" FROM THEIR DBS IMPLANT DURING A NERVE CONDUCTION STUDY IN 2020. THEY DO NOT REMEMBER IF THEY TURNED BOTH OF THE IMPLANTS OFF BEFORE THE STUDY. PATIENT DISCONTINUED THE STUDY AFTER THE SECOND SHOCKING INCIDENT. THE ISSUE RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 19746735 ↗
• InjuryJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S INS WAS EXPLANTED AND REPLACED IN JANUARY 2019 AS THE DEVICE HAD MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627553 ↗
• MalfunctionApr 15, 2024Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  THE PATIENT (PT) REPORTED THAT THEIR DBS SETTINGS WERE A LOT HIGHER IN THE BEGINNING AND PATIENT HAD THEM LOWERED BECAUSE THEY FELT LIKE THEY WERE GETTING ELECTROCUTED CONSTANTLY ON THE HIGHER SETTING. PT SAID THEY HAVE DBS FOR TREMOR AND THEY SAID THAT WITH A LOWER SETTING THEIR TREMOR WASN'T AS CONTROLLER BUT THEY WERE FINE WITH THAT BECAUSE THEY DIDN'T HAVE THE DISCOMFORT AT A LOWER SETTING. PATIENT SAID WHAT'S A LITTLE BIT OF SHAKING WHEN THEY HAVE TREMOR AND BEFORE GETTING THE DBS THEIR TREMOR WAS A LOT WORSE SO THE DBS SURGEON DID A GOOD JOB. THE PATIENT SAID THEY WERE LOOKING FOR A NEW MANAGING HEALTHCARE PROVIDER (HCP)  BECAUSE THEY WANTED TO FIND ANY HCP THEY COULD WORK WITH REGARDING SETTINGS AND SAID THE HCP HAD JUST KIND OF DECIDED ON THE SETTING THEY WANTED THE PATIENT TO BE ON AND PATIENT WANTED MORE INPUT. PS EMAILED PT HCP LISTINGS AND REVIEWED ROLE OF MANUFACTURER REPRESENTATIVE (REP).

  Patient problems: Discomfort; Electric Shock; Shaking/Tremors

  MAUDE report 19108094 ↗
• MalfunctionMar 8, 2024Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE CORD ON THE DESKTOP CHARGER WAS DAMAGED. THE PATIENT CALLED BACK AND STATED ACCIDENTLY RETURNING THE AC POWER CORD WHEN RETURNING THE DTC. PATIENT CALLED BACK AGAIN ANDS STATED THEY RECEIVED A RECHARGER HARNESS AND NOT THE AC POWER CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871602 ↗
• MalfunctionMar 6, 2024Battery Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Battery Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT RECHARGER TURNS OFF AFTER ABOUT 5-10 MINUTES AFTER PATIENT STARTS TO CHARGE INS AND SHOWS A PICTURE OF A PLUG. PATIENT STATES NO DAMAGE SEEN ON DESKTOP CHARGER (DTC) OR RECHARGER. THE PATIENT CALLED BACK TO REPORT THAT THEY RECEIVED A NEW DTC, BUT IT DID NOT RESOLVE THE ISSUE. THE PATIENT STATED THAT THE RECHARGER STILL DOES NOT TAKE A CHARGE FROM THE DTC, AND THEY SEE THE 'CHARGE YOUR RECHARGER' WARNING SCREEN EVEN WHEN THE DTC IS CONNECTED TO THE RECHARGER. THE PATIENT CONFIRMED THE POWER INDICATOR ON THE AC POWER SUPPLY WAS LIT GREEN. PATIENT'S WIFE CALLED BACK TO REQUEST RECHARGER BE SENT TO PT BECAUSE RECHARGER STILL WASN'T CHARGING AFTER PT RECEIVED REPLACEMENT DTC AND PT HADN'T CHARGED IN 4 DAYS. PATIENT REPRESENTATIVE (PT REP) SAID THEY TALKED TO MANUFACTURER REPRESENTATIVE AND WAS TOLD TO REQUEST THE RECHARGER BECAUSE THE PATIENT WASN'T INTERESTED IN UPDATING TO THE WIRELESS RECHARGER (WR). PT REP SAID PT HAD TREMOR SO EVEN WITH THE RECHARGING HOLSTER CHARGING WAS DIFFICULT BECAUSE THE PT MOVED AROUND. PT REP SAID ONLY WAY PT WAS ABLE TO CHARGE WAS WITH ADHESIVE DISCS SO PT WAS GOING TO STICK WITH RECHARGER. PT REP MENTIONED PT HAD DBS HCP APPOINTMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 18847829 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Insufficient Device Problem Information; Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "JUST QUIT" ABOUT 3 YEARS AGO AND PATIENT HAS NEVER TRIED TO GET IT TURNED ON. CALLER UNSURE WHY INS TURNED OFF AND IS NOT SURE IF IT WAS BECAUSE OF END OF SERVICE (EOS). CALLER STATED THE HEALTHCARE PROVIDER (HCP) WOULD LIKE TO DO A COMPATIBILITY TEST TO MAKE SURE THERE IS NO INTERFERENCE BETWEEN THE DEEP BRAIN STIMULATION (DBS) AND NEWLY IMPLANTED PACEMAKER. CALLER STATES THE HCP SAID PATIENT NEEDS TO HAVE A BATTERY CHARGER. AGENT REVIEWED PATIENT DOES NOT HAVE A RECHARGEABLE INS. CALLER STATES THE HOSPITAL TRIED TURNING ON THE PROGRAMMER AND IT DIDN'T WORK AND CALLER STATED THEY NEED TO GET NEW BATTERIES FOR IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634324 ↗
• MalfunctionJan 29, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULDN'T POWER ON AFTER TRYING NEW BATTERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601785 ↗
• MalfunctionJan 29, 2024Failure to Power Up; Audible Prompt/Feedback Problem; Failure to Power Up; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT THE PATIENT REPLACED THE BATTERIES ON THE PATIENT PROGRAMMER (PP) AND IT STILL WON'T TURN ON. THE PATIENT ALSO MENTIONED THAT PP PLAYS A TUNE. THE PATIENT WILL FOLLOW UP WITH HER HEALTHCARE PROVIDER (HCP) IF REPLACEMENT STILL PLAYS A TUNE. THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596706 ↗
• MalfunctionNov 13, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DESKTOP CHARGER HAD A BROKEN CONNECTOR PIN. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124504 ↗
• MalfunctionNov 13, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DESKTOP CHARGER HAD A BROKEN CONNECTOR PIN. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124244 ↗
• InjuryAug 22, 2023Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY DIDN'T KNOW WHAT LED TO THE LONGEVITY ISSUE. THE DEFECTIVE INS WAS REMOVED AND REPLACED WITH A NEW INS WHICH RESOLVED THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 17599894 ↗
• MalfunctionJul 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR INS MOVES "UP, DOWN, SIDEWAYS, BACK AND FORTH" BECAUSE THE PATIENT HAD SO MANY DIFFERENT BATTERIES IMPLANTED OVER THE YEARS. THE CALLER STATED THAT THE EVENT DATE WAS "10 OR 12 YEARS AGO." AS A RESULT, THE CALLER STATED THAT THE INS WON'T STAY IN PLACE WHEN THE PATIENT CHARGES IT. SEE RELATED EVENTS FOR DIFFERENT INSS OVER THE YEARS LAST 10 OR 12 YEARS: (B)(4) INS MOVEMENT - CURRENT, (B)(4) INS MOVEMENT - 2011, AND (B)(4) INS MOVEMENT ¿ 2012. REGULATORY REPORT #3004209178-2023-13247.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430779 ↗
• MalfunctionJul 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR INS MOVES "UP, DOWN, SIDEWAYS, BACK AND FORTH" BECAUSE THE PATIENT HAD HAD SO MANY DIFFERENT BATTERIES IMPLANTED OVER THE YEARS. THE CALLER STATED THAT THE EVENT DATE WAS "10 OR 12 YEARS AGO." AS A RESULT, THE CALLER STATED THAT THE INS WON'T STAY IN PLACE WHEN THE PATIENT CHARGES IT. SEE RELATED EVENTS FOR DIFFERENT INSS OVER THE YEARS LAST 10 OR 12 YEARS: PE 705724991 INS MOVEMENT - CURRENT, PE 705731881 INS MOVEMENT - 2011, AND PE 705731884 INS MOVEMENT - 2013. REGULATORY REPORT# 3004209178-2023-13247

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430687 ↗
• MalfunctionJul 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR INS MOVES "UP, DOWN, SIDEWAYS, BACK AND FORTH" BECAUSE THE PATIENT HAD HAD SO MANY DIFFERENT BATTERIES IMPLANTED OVER THE YEARS. THE CALLER STATED THAT THE EVENT DATE WAS "10 OR 12 YEARS AGO." AS A RESULT, THE CALLER STATED THAT THE INS WON'T STAY IN PLACE WHEN THE PATIENT CHARGES IT. SEE RELATED EVENTS FOR DIFFERENT INSS OVER THE YEARS LAST 10 OR 12 YEARS: (B)(4) INS MOVEMENT - CURRENT, (B)(4) INS MOVEMENT - 2011, AND (B)(4) INS MOVEMENT - 2013. REGULATORY REPORT# 3004209178-2023-13247.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430669 ↗
• DeathJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023 AND STATED THAT THE DEATH WAS RELATED TO THE DBS IMPLANT. THE CALLER STATED THAT THE PATIENT LOST GROUND AFTER THE IMPLANTS WERE REMOVED. THE CALLER STATED THAT THE MONDAY PRIOR TO THE PATIENTS DEATH , THE PATIENTS BLOOD PRESSURE GOT REALLY HIGH AND WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE DUE THE PATIENT NOT BEING ABLE TO STAND UP FROM LACK OF STRENGTH. THE CALLER STATED THEY MADE THE PATIENT A DO NOT RESUSCITATE ON THE SECOND DAY (WHILE IN THE HOSPITAL) , BECAUSE THE PATIENT WAS DECLINING AND THEY WERE EVERYTHING THEY COULD DO FOR HER. THE CALLER STATED THAT WHEN THE PATIENT WENT INTO THE HEALTHCARE PROVIDER (HCP) OFFICE IN JULY THERE WAS A "BIG HOLE IN HER HEAD" WHERE THE INFECTION WAS . AND THAT THE PATIENT NEVER RECOVERED FROM HAVING THE IMPLANTABLE NEUROSTIMULATOR EXPLANTED. FOR RELEVANT MEDICAL HISTORY THE PATIENT HAD A PACEMAKER IMPLANTED IN SEPTEMBER. OTHER RELEVANT MEDICAL HISTORY: THE PATIENT WAS ON METOPROLOL AND XARELTO DURING THE TIME OF HER DEATH. ON THE PATIENTS DEATH CERTIFICATE ACUTE HYPOXIC RESPIRATORY FAILURE, ISCHEMIC STROKES AND ACUTE HYPERCAPNIC FAILURE IS LISTED AS PATIENTS CAUSE OF DEATH. REFER

  Patient problems: High Blood Pressure/ Hypertension; Insufficient Information; Muscle Weakness/Atrophy; Respiratory Failure; Stroke/CVA

  MAUDE report 17426723 ↗
• DeathJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023 AND STATED THAT THE DEATH WAS RELATED TO THE DBS IMPLANT. THE CALLER STATED THAT THE PATIENT LOST GROUND AFTER THE IMPLANTS WERE REMOVED. THE CALLER STATED THAT THE MONDAY PRIOR TO THE PATIENTS DEATH , THE PATIENTS BLOOD PRESSURE GOT REALLY HIGH AND WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE DUE THE PATIENT NOT BEING ABLE TO STAND UP FROM LACK OF STRENGTH. THE CALLER STATED THEY MADE THE PATIENT A DO NOT RESUSCITATE ON THE SECOND DAY (WHILE IN THE HOSPITAL) , BECAUSE THE PATIENT WAS DECLINING AND THEY WERE EVERYTHING THEY COULD DO FOR HER. THE CALLER STATED THAT WHEN THE PATIENT WENT INTO THE HEALTHCARE PROVIDER (HCP) OFFICE IN JULY THERE WAS A "BIG HOLE IN HER HEAD" WHERE THE INFECTION WAS . AND THAT THE PATIENT NEVER RECOVERED FROM HAVING THE IMPLANTABLE NEUROSTIMULATOR EXPLANTED. FOR RELEVANT MEDICAL HISTORY THE PATIENT HAD A PACEMAKER IMPLANTED IN SEPTEMBER. OTHER RELEVANT MEDICAL HISTORY: THE PATIENT WAS ON METOPROLOL AND XARELTO DURING THE TIME OF HER DEATH. ON THE PATIENTS DEATH CERTIFICATE ACUTE HYPOXIC RESPIRATORY FAILURE, ISCHEMIC STROKES AND ACUTE HYPERCAPNIC FAILURE IS LISTED AS PATIENTS CAUSE OF DEATH.

  Patient problems: High Blood Pressure/ Hypertension; Insufficient Information; Muscle Weakness/Atrophy; Respiratory Failure; Stroke/CVA

  MAUDE report 17426545 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO SWELLING AND PAIN, SUSPICIOUS FOR INFECTION. THE LEFT LEAD WAS CAPPED AND REMAINS IMPLANTED. THE ISSUE WAS RESOLVED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17339245 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO SWELLING AND PAIN, SUSPICIOUS FOR INFECTION. THE LEFT LEAD WAS CAPPED AND REMAINS IMPLANTED. THE ISSUE WAS RESOLVED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17339237 ↗
• MalfunctionJun 30, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THEY DIDN¿T NOTICE THE FRACTURE UNTIL DURING THE OPERATION FOR AN UNRELATED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238535 ↗
• InjuryMar 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THERAPY WAS WORKING AND THE SYSTEM HAD NO SHORTS OR OPEN CIRCUITS. PER THE HCP THE PATIENT HAD NO OTHER PROBLEMS WITH THE DBS SYSTEM.

  Patient problems: Erosion

  MAUDE report 16553788 ↗
• MalfunctionFeb 6, 2023Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE PACEMAKER REP SAW THE PATIENT AND NOTED THERE WASN¿T ANY INTERFERENCE; IT WAS JUST A PACING PROGRAMMING SETTING THAT NEEDED TO BE CHANGED AND THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 16304850 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO INFECTION AND HARDWARE EROSION. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE ARE KNOWN. NO TROUBLESHOOTING OR ACTIONS/INTERVENTIONS WERE TAKEN. THE ISSUE WAS RESOLVED WITH THE EXPLANT. PATIENT CAME IN THROUGH THE EMERGENCY ROOM (ER) WITH A HARDWARE EROSION ON THE LEFT SIDE. THE LEFT SIDE WAS REMOVED ON (B)(6) 2022. PATIENT CAME IN AGAIN THROUGH THE EMERGENCY ROOM WITH ANOTHER WOUND EROSION/INFECTION. RIGHT SIDE WAS REMOVED ON (B)(6) 2022. SURGEON IS NOT PLANNING ON REPLACING THE HARDWARE DUE TO AGE AND OTHER MEDICATIONS THE PATIENT IS CURRENTLY TAKING.

  Patient problems: Erosion; Pocket Erosion; Unspecified Infection

  MAUDE report 16016719 ↗

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.