Activa® SC 37603 (UDI 00643169864214)Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00643169864214), received between May 24, 2018 and Jul 30, 2026 — classified as 1 death, 219 injuries, 223 malfunctions.

The most frequently reported specific device problem is “High impedance” (58 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, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 443 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Malposition of Device

  It was reported that It was reported that the patient (pt) needed to go to the ER this weekend because they think pt is having gallbladder and appendix issues and their smart programmer is lost or stolen and they may need to turn therapy off for surgery. It was also reported that the caller said patient (pt) has been going to a doctor out of state even though they live elsewhere because the doctor who put in their most current implantable neurostimulator ((b)(6)2023) installed their wiring all wrong. Caller said the wiring was choking the pt because it crisscrossed in the front of their neck and they were flown to have it taken out and redone. Redirected to their doctor.

  Patient problems: Choking

  MAUDE report 50084107 ↗
• InjuryJul 30, 2026Malposition of Device

  It was reported that the patient needed to go to the ER this weekend because they think patient is having gallbladder and appendix issues and their smart programmer is lost or stolen and they may need to turn therapy off for surgery. It was also reported that the caller said patient has been going to a doctor out of state even though they live elsewhere because the doctor who put in their most current implantable neurostimulator (on (b)(6) 2023) installed their wiring all wrong. Caller said the wiring was choking the patient because it crisscrossed in the front of their neck and they were flown to have it taken out and redone. Redirected to their doctor.

  Patient problems: Choking

  MAUDE report 50084100 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REMOVAL OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE REASON FOR DEVICE REMOVAL IS UNKNOWN. INFORMATION HAS BEEN CONFIRMED BY HEALTHCARE PROVIDER (HCP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904947 ↗
• InjuryFeb 3, 2026Insufficient Device Problem Information

  THE CALLER REPORTED A HISTORICAL EVENT. THE CALLER REPORTED THAT THEY HAD A KINKED WIRE WITH THE FIRST SYSTEM IN 2019 AND THAT IS WHY IT WAS REPLACED IN 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250505 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) HAD TO BE EXPLANTED DUE TO INFECTION. THE INDIVIDUAL UNDERWENT TREATMENT FOR THE INFECTION WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PIC INTRAVENOUS) FOR SIX WEEKS. AFTER TREATMENT, A NEUROSTIMULATOR WAS RE-IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24146032 ↗
• MalfunctionJan 2, 2026Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO BATTERY DEPLETION WITHOUT ALLEGATION OF SYMPTOMS OR DEVICE MALFUNCTION. ORIGINAL IMPLANT DATE OF THE DEVICE IS NOT KNOWN AND THE USE BEFORE DATE IS 02/14/2021. U TO VERIFY WHETHER DEVICE WAS IMPLANTED AFTER USE BEFORE DATE OR IF INFORMATION WAS PROVIDED IN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943500 ↗
• InjuryDec 19, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT NEUROLOGY IS REPORTING THAT IMPEDANCE ON THE RIGHT SIDE IS OUT OF RANGE. HEALTHCARE PROVIDER (HCP) GOT AN X-RAY THAT SHOWS NO OBVIOUS DISCONTINUANCES IN THE LEADS. PATIENT (PT) IS SCHEDULED FOR NORMAL BATTERY REPLACEMENT ON (B)(6) 2026 HCP WILL EXPLORE IMPEDANCE ISSUE DURING THE SURGERY. IT IS UNKNOWN IF LEAD OR EXTENSION IS CAUSING HIGH IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854829 ↗
• InjuryNov 18, 2025Migration or Expulsion of Device; Unintended Collision; Migration or Expulsion of Device; Unintended Collision

  (B)(6) 2025: IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS HAS COME THROUGH THE SCALP SOME. CALLER DOESN'T HAVE ANY FURTHER DETAILS ABOUT THE NATURE OF THE EROSION, SIZE, ETC. IMPEDANCES REMAIN NORMAL. 2025-NOV-03: ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE LEAD COMING THROUGH THE SCALP WAS THAT THE PATIENT HAD SQUAMOUS CELL CARCINOMA (SCC) A FEW YEARS AGO. THEY UNDERWENT WIDE EXCISION WITH FLAP RECONSTRUCTION WITH THE LEADS RE-TUNNELED AROUND THE FLAP. PATIENT RECENTLY SUSTAINED A FALL WITH TRAUMA TO THE L SCALP, RESULTING IN NON-HEALING WOUND WITH HARDWARE EXPOSURE. PATIENT COMPLETED COURSE OF ANTIBIOTICS WITHOUT IMPROVEMENT. GIVEN EXPOSED HARDWARE, IT WAS RECOMMENDED TO EXPLANT THE DEVICES IN ORDER TO PREVENT POTENTIAL DEVELOPMENT OF INTRACRANIAL INFECTION. DEVICE WAS EXPLANTED. PATIENT HAD A WORSENING OF THEIR PARKINSON'S SYMPTOMS.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 23581155 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT "REMOVED ONE" AND PUT A NON-MANUFACTURER IMPLANT IN. PATIENT CLARIFIED THEY HAD "ONE SIDE DONE THAT WAS [MANUFACTURER'S]" AND STATED THEIR SECOND SURGERY THEY HAD THE SECOND MANUFACTURER LEAD PUT IN AND REPORTED THEY GOT A STAPH INFECTION (PATIENT CLARIFIED THEY GOT STAPH INFECTION WITH IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS REMOVED ON (B)(6) 2019. PATIENT REPORTED THEIR THIRD SURGERY THEY REMOVED A LEAD AND PUT A NON-MANUFACTURER LEAD ON THE OTHER SIDE, SO PATIENT STATED THEY NOW HAVE A MIXED SYSTEM. PATIENT CLARIFIED THEIR MIX SYSTEM INCLUDES THAT THEY HAVE A MANUFACTURER LEAD, A NON-MANUFACTURER LEAD, WITH A NONMANUFACTURER INS. PATIENT CLARIFIED THEY DO NOT HAVE A MANUFACTURER INS ANYMORE. REVIEWED DEVICE REGISTRATION INFORMATION AND DIFFERENCE BETWEEN IMPLANT AND LEAD. PATIENT MENTIONED THEY "STARTED WITH MANUFACTURER ON BOTH SIDES" (PATIENT DID NOT CLARIFY THIS). WHEN ASKED FOR DATE OF STAPH INFECTION, PATIENT STATED IT WAS NOT TOO LONG AFTER "IT WAS IMPLANTED" AND STATED "SHE" WAS WORRIED ABOUT IT "GROWING INTO MY BRAIN ON THE HARDWIRE" AND STATED IT WAS EVIDENT THAT IT NEEDED TO BE EXPLANTED (PATIENT DID NOT CLARIFY THIS STATEMENT).

  Patient problems: Bacterial Infection

  MAUDE report 23536443 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CALLER STATED ON (B)(6) 2018, THEY OBSERVED PUS POURING OUT BEHIND THE PATIENT'S EAR, WHICH WAS DETERMINED TO BE DUE TO AN INFECTION RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), RESULTING IN REMOVAL OF THE RIGHT INS. THREE YEARS LATER, THE CALLER NOTICED PUS COMING FROM BEHIND THE PATIENT'S LEFT EAR AND EVENTUALLY FROM THE TOP OF THE PATIENT'S HEAD, WHICH WAS ATTRIBUTED TO AN INFECTION INVOLVING THE OTHER INS, LEADING TO ITS REMOVAL ON THANKSGIVING.

  Patient problems: Unspecified Infection

  MAUDE report 23519783 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CALLER STATED ON (B)(6) 2018, THEY OBSERVED PUS POURING OUT BEHIND THE PATIENT'S EAR, WHICH WAS DETERMINED TO BE DUE TO AN INFECTION RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), RESULTING IN REMOVAL OF THE RIGHT INS. THREE YEARS LATER, THE CALLER NOTICED PUS COMING FROM BEHIND THE PATIENT'S LEFT EAR AND EVENTUALLY FROM THE TOP OF THE PATIENT'S HEAD, WHICH WAS ATTRIBUTED TO AN INFECTION INVOLVING THE OTHER INS, LEADING TO ITS REMOVAL ON THANKSGIVING.

  Patient problems: Unspecified Infection

  MAUDE report 23519773 ↗
• MalfunctionAug 5, 2025Malposition of Device; Battery Problem; Malposition of Device; Battery Problem

  IT WAS REPORTED THAT THE PATIENT¿S SYSTEM HAD BEEN TURNED OFF AND NON-OPERABLE SINCE 2021 AFTER IT WAS DISCOVERED THAT THE LEAD WAS INCORRECTLY PLACED AND NOT PROGRAMMABLE. THE CALLER MENTIONED THAT IN 2021, THE PATIENT WAS USING 5 VOLTS OF ENERGY AND DEPLETING IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES QUICKLY. THE PATIENT NOW REQUIRES A BRAIN MRI. PATIENT SERVICES REVIEWED MRI GUIDELINES AND TRANSFERRED THE CALLER TO NAS FOR ASSISTANCE FROM A LOCAL MANUFACTURER REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710860 ↗
• MalfunctionMay 25, 2025Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT STATED THAT THEIR IMPLANTED NEUROSTIMULATORS ARE GETTING VERY LOW. AGENT REVIEWED ERI (ELECTIVE REPLACEMENT INTERVAL) AND EOS WITH THE PATIENT. PATIENT STATED THAT THEY ARE AT 2.58V AND THEY DON'T SEE A ERI MESSAGE. PATIENT SAID THAT THEY NOTICED THIS ISSUE ALMOST ALL LAST WEEK. AGENT HAD THE PATIENT CONNECT WITH THEIR IMPLANT AND PATIENT CONFIRMED SEEING ERI. THE ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ASSIST WITH GETTING THE IMPLANTS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082526 ↗
• InjuryApr 24, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) WHO REPORTED THE DEVICE WAS REPLACED FOLLOWING REPEATED SHOCKING SENSATIONS.

  Patient problems: Electric Shock

  MAUDE report 21897258 ↗
• InjuryJan 10, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CAUSE OF THE BATTERY BEING OUT WAS DUE TO IT BEING AT END OF LIFE. THE PATIENT HAD THEIR BATTERY REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125046 ↗
• InjuryDec 30, 2024Adverse 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, WHO HAD UNDERGONE DEEP BRAIN STIMULATION, WAS PLACED ON A HOLD DUE TO BEING SUICIDAL. PROVIDER IS UNCERTAIN WHETHER THE PATIENT'S MOOD CHANGES ARE RELATED TO THE DEEP BRAIN STIMULATION OR DEPRESSION OVER THE LACK OF CONTROL OF PARKINSON'S SYMPTOMS. NO SURGICAL INTERVENTION OCCURRED, NOR WAS ANY PLANNED. THE PATIENT REMAINED ALIVE WITH NO INJURY.

  Patient problems: Suicidal Ideation

  MAUDE report 21034911 ↗
• MalfunctionDec 6, 2024Low impedance; Low impedance

  IT WAS INITIALLY REPORTED THAT THERE WAS AN ISSUE INVOLVING A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) RELATED TO DEFIBRILLATION OR CARDIOVERSION, HOWEVER, AFTER AN MDT REP WAS ABLE TO TURN ON AND INTERROGATE BOTH OF THE PATIENT'S IMPLANTS, IT WAS FOUND THAT THERE WERE NO ISSUES WITH THE DEVICE AND/OR THERAPY. DURING INTERROGATION, IT WAS FOUND THAT IMPEDANCES ON THE RIGHT IMPLANT WERE NORMAL BUT THE LEFT IMPLANT SHOWED BIPOLAR CONTACTS 0 AND 1 HAD LOW IMPEDANCE. THE PATIENT IS CURRENTLY NOT RECEIVING THERAPY ON THESE CONTACTS AND IT IS UNKNOWN IF THIS WAS NEW OR PRIOR EXISTING. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869809 ↗
• InjuryOct 24, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NORMAL BATTERY DEPLETION REPLACEMENT. IMPEDANCES WERE NOT IN RANGE. EARLIEST RECORD OF ABNORMAL IMPEDANCES ARE (B)(6) 2021, LONG TERM KNOW PROBLEMS. NO IMPACT TO THE PATIENT REPORTED.

  Patient problems: Muscular Rigidity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522715 ↗
• MalfunctionAug 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAS NOT BEEN WORKING FOR THE LAST 4 YEARS BECAUSE THE PATIENT'S HUSBAND WAS ILL AND THE PATIENT WAS "DOING OTHER STUFF AND NOT PAYING ATTENTION TO IT." THEY MENTIONED THAT THE PATIENT NO LONGER HAS A MANAGING HEALTHCARE PROVIDER AND REQUESTED PHYSICIAN LISTINGS. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THERE WAS NO ISSUE WITH THE DEVICE; THE BATTERY STOPPED WORKING AND TWO DIFFERENT PHYSICIANS HAD RETIRED OR MOVED THEIR PRACTICE. NOTHING WAS DONE TO RESOLVE THE ISSUE AT THIS TIME AS ¿OTHER LIFE ISSUES POPPED UP.¿ THE PATIENT WAS GOING TO CONTACT A NEW PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966286 ↗
• MalfunctionJul 25, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WILL NOT POWER ON EVEN WITH NEW BATTERIES. DURING DISCUSSION IT WAS MENTIONED THAT THEY HAVE A SAMSUNG PHONE THAT THEY USED. TECH SERVICES REVIEWED THAT WOULD BE THE NEWEST CONTROLLER TO BE USING. AT THIS TIME THERE IS NO NEED TO REPLACE THE PROGRAMMER AS THEY HAVE THE HANDSET AND COMMUNICATOR. PATIENT IS IN HOSPITAL FOR STROKE SYMPTOMS (UNKNOWN IF RELATED TO DBS) AND IS NEEDING AN MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828105 ↗
• MalfunctionJun 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THAT THE PATIENT'S PROGRAMMER STOPPED WORKING A FEW WEEKS AGO FOR NO APPARENT REASON AND THEY GOT THE SHAKES. THEY PUT NEW BATTERIES IN IT AND THE PATIENT PROGRAMMER IS SHOWING EOS. AGENT REVIEWED EOS WITH PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. PATIENT WAS DISSATISFIED WITH LONGEVITY AND REPORTED THAT THEY WERE TOLD BY THEIR DOCTOR THAT THE BATTERY WOULD LAST 10 YEARS. AGENT RECOMMENDED REVIEWING LONGEVITY CONCERNS WITH HEALTHCARE PROVIDER.

  Patient problems: Shaking/Tremors

  MAUDE report 19610296 ↗
• MalfunctionJun 21, 2024Failure to Deliver Energy; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Energy; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE LAST TIME THE PATIENT SAW THE HEALTHCARE PROVIDER (HCP) IN MARCH THEY WERE TOLD TO MONITOR/CHECK THE DEVICE. THE CALLER STATED THAT SINCE SEEING THE HCP IN MARCH THEIR WHOLE RIGHT SIDE OF THEIR BODY IS NUMB REGARDLESS IF THE STIMULATION IS ON OR OFF. THE CALLER STATED THAT THE HCP DID NOT MAKE ANY ADJUSTMENTS TO THEIR THERAPY AT THAT TIME. THE CALLER STATED THAT A HCP TOLD THEM A FEW YEARS AGO THAT THE NUMBNESS IN THEIR ARM AND HAND IS DUE TO CARPAL TUNNEL. THE CALLER STATED THAT THEY THINK THEY HAVE A PINCHED NERVE IN THEIR BACK. THE CALLER STATED THAT THEY KEEP FEELING A ZAPPING BETWEEN THEIR SPINE AND SHOULDER. THE CALLER STATED ZAPPING HAS BEEN GOING ON SINCE MARCH. THE CALLER STATED THAT THEY FEELING A ZAPPING SENSATION ALL THE TIME. THE CALLER REPORTED THAT THEIR SISTER LIVES IN A BUILDING THAT MAY HAVE HIGH EMI. THE CALLER STATED THAT THE APARTMENT ROOM THEY WERE IN IS NEAR AN HIGH ELECTRICAL ROOM. THE CALLER STATED THAT WHEN THEY ARE IN THAT BUILDING THEIR " DEVICE GOES HAYWIRE" ( THE 37642). THE CALLER STATED THAT " IT GOES TO ONE SCREEN ONE MINUTE THEN GOES TO ANOTHER THE NEXT". THE CALLER DID NOT REPORT A CHANGE IN THERAPY WHEN THEY WERE IN THE B

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Electric Shock; Fall; Insufficient Information; Numbness; Paresthesia

  MAUDE report 19587223 ↗
• MalfunctionJun 21, 2024Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE LAST TIME THE PATIENT SAW THE HEALTHCARE PROVIDER (HCP) IN MARCH THEY WERE TOLD TO MONITOR/CHECK THE DEVICE. THE CALLER STATED THAT SINCE SEEING THE HCP IN MARCH THEIR WHOLE RIGHT SIDE OF THEIR BODY IS NUMB REGARDLESS IF THE STIMULATION IS ON OR OFF. THE CALLER STATED THAT THE HCP DID NOT MAKE ANY ADJUSTMENTS TO THEIR THERAPY AT THAT TIME. THE CALLER STATED THAT A HCP TOLD THEM A FEW YEARS AGO THAT THE NUMBNESS IN THEIR ARM AND HAND IS DUE TO CARPAL TUNNEL. THE CALLER STATED THAT THEY THINK THEY HAVE A PINCHED NERVE IN THEIR BACK. THE CALLER STATED THAT THEY KEEP FEELING A ZAPPING BETWEEN THEIR SPINE AND SHOULDER. THE CALLER STATED ZAPPING HAS BEEN GOING ON SINCE MARCH. THE CALLER STATED THAT THEY FEELING A ZAPPING SENSATION ALL THE TIME. THE CALLER REPORTED THAT THEIR SISTER LIVES IN A BUILDING THAT MAY HAVE HIGH EMI. THE CALLER STATED THAT THE APARTMENT ROOM THEY WERE IN IS NEAR AN HIGH ELECTRICAL ROOM. THE CALLER STATED THAT WHEN THEY ARE IN THAT BUILDING THEIR " DEVICE GOES HAYWIRE" ( THE 37642). THE CALLER STATED THAT " IT GOES TO ONE SCREEN ONE MINUTE THEN GOES TO ANOTHER THE NEXT". THE CALLER DID NOT REPORT A CHANGE IN THERAPY WHEN THEY WERE IN THE B

  Patient problems: Ambulation or Postural Difficulties; Electric Shock; Fall; Insufficient Information

  MAUDE report 19584863 ↗
• InjuryJun 20, 2024Premature Discharge of Battery; Premature Discharge of Battery

  THE PATIENT STATED THE IMPLANTED NEUROSTIMULATOR (INS) IS DEPLETED FOR THE RIGHT HAND SIDE OF HIS BODY. THEY WOULD LIKE A NEUROSURGEON TO INSTALL THE BATTERY PACK AND THE BRAIN IMPLANT AT THE SAME TIME. THE PATIENT WAS SHAKING DUE TO THE INS BEING DEPLETED. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE BATTERY EXPERIENCED PREMATURE DEPLETION. THE CIRCUMSTANCES THAT LED TO THE DEPLETION WAS UNKNOWN. THE PATIENT MENTIONED THAT HAD ANOTHER LEAD INSERTED ON THE OPPOSITE SIDE OF THE BRAIN AS THE DEVICE HAD BEEN A GREAT HELP.

  Patient problems: Shaking/Tremors

  MAUDE report 19573336 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER (HCP) REPORTED PATIENT HAD SEIZURES RECENTLY AND DOCTOR WANTED TO DO AN MRI. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Convulsion/Seizure

  MAUDE report 19180669 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, 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.