Activa® SC 37603 (UDI 00763000384340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00763000384340), received between Feb 1, 2021 and Jan 12, 2026 — classified as 47 injuries, 61 malfunctions.

The most frequently reported specific device problem is “High impedance” (19 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 108 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Failure to Deliver Energy; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY "WENT OUT" AND THE PATIENT HAD TO GO THROUGH A LOT OF SUFFERING BEFORE THEY COULD GET THE INS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24036951 ↗
• MalfunctionDec 17, 2025Low impedance; Battery Problem; Low impedance; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE EOS WAS DUE TO NORMAL BATTERY DEPLETION. REP REPORTED THE CAUSE OF THE SHORT WAS UNKNOWN. NORMAL BATTERY REPLACEMENT DID NOT RESOLVE THE SHORT SO THE REP REPROGRAMMED AROUND THE SHORT AND THAT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830251 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE REGARDING THE DEVICE REPLACEMENT AND EXPLANT. AT THE TIME OF REPLACEMENT, THE REP WAS NOTIFIED THAT THE SYSTEM HAD ALREADY BEEN EXPLANTED DUE TO INFECTION; HOWEVER, NO DETAILS ABOUT THE CAUSE OF THE INFECTION OR SPECIFICS REGARDING THE EXPLANT PROCEDURE WERE PROVIDED. THE HCP DID NOT HAVE ANY FURTHER INFORMATION. A NEW SYSTEM WAS IMPLANTED ON THE LEFT SIDE ON (B)(6)2025. NO FURTHER INFORMATION COULD BE PROVIDED DUE TO THE LIMITED DETAILS RECEIVED FROM THE PROVIDER.

  Patient problems: Unspecified Infection

  MAUDE report 23286166 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE REGARDING THE DEVICE REPLACEMENT AND EXPLANT. AT THE TIME OF REPLACEMENT, THE REP WAS NOTIFIED THAT THE SYSTEM HAD ALREADY BEEN EXPLANTED DUE TO INFECTION; HOWEVER, NO DETAILS ABOUT THE CAUSE OF THE INFECTION OR SPECIFICS REGARDING THE EXPLANT PROCEDURE WERE PROVIDED. THE HCP DID NOT HAVE ANY FURTHER INFORMATION. A NEW SYSTEM WAS IMPLANTED ON THE LEFT SIDE ON (B)(6) 2025. NO FURTHER INFORMATION COULD BE PROVIDED DUE TO THE LIMITED DETAILS RECEIVED FROM THE PROVIDER.

  Patient problems: Unspecified Infection

  MAUDE report 23285619 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING CAUSE OF THE REVISION ON JULY 24TH WAS IMPEDANCES WERE DETECTED ON THE EXTENSION DURING A BATTERY REPLACEMENT PROCEDURE DUE TO BATTERY DEPLETION. IMPEDANCES WERE RESOLVED WITH EXTENSION REVISION. IT IS UNKNOWN WHEN INFECTION WAS FIRST OBSERVED. PATIENT HAS SINCE HAD THEIR NEW BATTERY AND EXTENSION PLACED ON (B)(6) 2025. THE REP IS NOT AWARE OF ANY ISSUES WITH THE SYSTEM SINCE NEW BATTERY AND EXTENSION WERE PLACED.

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

  MAUDE report 22910222 ↗
• MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) STATED THAT ONE OF THE ELECTRODES IN THE SYSTEM WAS BROKEN. THE PATIENT CLARIFIED THAT THE DEVICE WAS PROGRAMMED SO THAT THE BROKEN ELECTRODE WAS NOT USED. A MAGNETIC RESONANCE IMAGING (MRI) ELIGIBILITY FORM WAS REVIEWED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22797129 ↗
• InjuryJul 24, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR WAS IMPLANTED AFTER ITS USE BEFORE DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586472 ↗
• MalfunctionJul 8, 2025Failure to Deliver Energy; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem; Data Problem; Failure to Deliver Energy; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem; Data Problem

  THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441660 ↗
• 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 22082523 ↗
• MalfunctionMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION SYSTEM, SPECIFICALLY THE IMPLANTABLE PULSE GENERATOR (IPG), WAS DESCRIBED AS "DEAD" AND "MALFUNCTIONING." THERE WERE POTENTIAL CONCERNS REGARDING THE END OF SERVICE (EOS) FOR THE IMPLANTABLE NEUROSTIMULATOR. A HEALTHCARE PROFESSIONAL INDICATED THAT THE DEEP BRAIN STIMULATION WAS NOT FUNCTIONING AND REQUESTED A REPRESENTATIVE TO EVALUATE THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021104 ↗
• MalfunctionMay 14, 2025Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO CONNECT TO THE COMMUNICATOR, BUT THAT THEY ARE TRYING TO CONNECT TO THE PATIENT'S INS AND THE TABLET IS SHOWING A MESSAGE STATING, "INVALID DATA: ALL SETTINGS WILL BE CLEARED" WITH THE CODE 0E2BEE93. REP STATES SHE TRIED RESTARTING THE TABLET AND THIS DID NOT RESOLVE. WHEN SHE HITS CANCEL, IT LEAVES THE SESSION. REP STATES THAT WHEN SHE HITS CONTINUE IT CLEARS THE THERAPY PROGRAMMING AND JUST SHOWS THE VOLTAGE. REP ALSO STATES THAT WHEN SHE INITIALLY WENT INTO THE REPORT, IT DOESN'T LOOK LIKE IT EVEN TRIED TO CONNECT TO THE BATTERY. REP ALSO STATES THE PHYSICIAN A FEW WEEKS BACK HAD DIFFICULTY CONNECTING TO THE INS AS WELL. REP STATES THE BATTERY IS AT ERI AND IS GETTING REPLACED TODAY, SO SHE WILL CONTACT THE NEUROLOGIST FOR THE SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019725 ↗
• InjuryApr 17, 2025Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, WHO HAD BEEN IMPLANTED WITH A SOLITARY LEFT DEEP BRAIN STIMULATION (DBS) LEAD SIX YEARS AGO, PRESENTED TO THE HEALTHCARE PROVIDER WITH PROFOUND TREMORS IN ALL FOUR LIMBS, WHICH HAD BEGUN SEVERAL DAYS PRIOR. THE IMPLANTABLE PULSE GENERATOR (IPG) SHOWED AN END OF SERVICE (EOS) ALERT. THE PATIENT WAS COMPLETELY IMMOBILIZED, UNABLE TO WALK OR FEED THEMSELVES, AND HAD BEEN BEDRIDDEN AT HOME FOR SEVERAL DAYS. GIVEN THE PROGRESSION OF TREMORS, PARTICULARLY ON THE LEFT SIDE, THE PATIENT EXPRESSED INTEREST IN CONTRALATERAL LEAD PLACEMENT. DUE TO THE ADVANCED CLINICAL STATUS AND URGENT NEED FOR IPG EXCHANGE, THE PATIENT WAS ADMITTED EMERGENTLY FROM THE CLINIC TO THE HOSPITAL. THE PATIENT ALSO WANTED TO CONVERT TO A DUAL-CHANNEL SYSTEM IN ANTICIPATION OF CONTRALATERAL LEAD PLACEMENT. IMPEDANCE CHECKS SHOWED NORMAL READINGS ACROSS ALL FOUR CHANNELS AND REMAINED STABLE THROUGHOUT THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION, WHICH THE HCP CONFIRMED THAT THE BATTERY REACHED THE END OF SERVICE (EOS) BASED ON NORMAL USE BUT THE PATIENT DIDN'T FOLLOW UP WITH THE HCP TO AVOID SYMPTOMS. THE PATIENT'S SYMPTOMS RESOLVED AFTER THE REPLA

  Patient problems: Ambulation or Postural Difficulties; Feeding Problem; Shaking/Tremors

  MAUDE report 21862099 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) PRESENTED TO THE FACILITY ON (B)(6) 2025 AND WAS ADMITTED ON (B)(6) 2025, WITH ALTERED MENTAL STATUS AND AN INABILITY TO SPEAK. THE CALLER REQUESTED A MANUFACTURER REPRESENTATIVE TO CHECK THE PATIENT'S SYSTEMS. TROUBLESHOOTING WAS NOT PERFORMED, AND THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER WAS REDIRECTED TO NAS FOR FURTHER ASSISTANCE.

  Patient problems: Cognitive Changes; Dysphasia

  MAUDE report 21238905 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) PRESENTED TO THE FACILITY ON (B)(6) 2025, AND WAS ADMITTED ON (B)(6) 2025, WITH ALTERED MENTAL STATUS AND AN INABILITY TO SPEAK. THE CALLER REQUESTED A MANUFACTURER REPRESENTATIVE TO CHECK THE PATIENT'S SYSTEMS. TROUBLESHOOTING WAS NOT PERFORMED, AND THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER WAS REDIRECTED TO NAS FOR FURTHER ASSISTANCE.

  Patient problems: Cognitive Changes; Dysphasia

  MAUDE report 21238903 ↗
• MalfunctionDec 11, 2024Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT THERE WAS A CONCERN REGARDING THE DEEP BRAIN STIMULATION THERAPY NOT FUNCTIONING PROPERLY WITH THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. SYMPTOMS REPORTEDLY WORSENED FOLLOWING THE PLACEMENT OF A LOOP RECORDER ON (B)(6) 2024. THE HEALTHCARE PROVIDER EXPRESSED CONCERNS ABOUT POTENTIAL INTERACTIONS BETWEEN THE CARDIAC MONITOR AND THE INS. TROUBLESHOOTING WAS NOT REQUIRED, AND THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE RESOLUTION INVOLVED EDUCATING THE CUSTOMER AND PROVIDING INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20909814 ↗
• MalfunctionDec 11, 2024Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT THERE WAS A CONCERN REGARDING THE DEEP BRAIN STIMULATION THERAPY NOT FUNCTIONING PROPERLY WITH THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. SYMPTOMS REPORTEDLY WORSENED FOLLOWING THE PLACEMENT OF A LOOP RECORDER ON OCTOBER 24, 2024. THE HEALTHCARE PROVIDER EXPRESSED CONCERNS ABOUT POTENTIAL INTERACTIONS BETWEEN THE CARDIAC MONITOR AND THE INS. TROUBLESHOOTING WAS NOT REQUIRED, AND THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE RESOLUTION INVOLVED EDUCATING THE CUSTOMER AND PROVIDING INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20909813 ↗
• MalfunctionSep 20, 2024Vibration; Vibration

  IT WAS REPORTED BY THE PATIENT THAT THEY DIDN'T LIKE THE BUZZ IN THEIR BRAIN WHEN THE HEALTHCARE PROVIDER (HCP) CHECKED THE DEVICE. THE PATIENT SAID THEY FELT THE BUZZING WHEN THE HCP CHECKED THE SYSTEM'S INTEGRITY, WHICH STARTED "WAY BACK" WHEN THEY FIRST GOT THE DEVICE. THE PATIENT SAID THE LAST TIME THEY WENT TO THE DOCTOR, IT DIDN'T DO IT, AND IT HAD BEEN ALL THE TIMES BEFORE, AND THEY TOLD THE PATIENT IT WAS BECAUSE THEIR BRAIN DIDN'T LIKE TO BE MESSED WITH. THE PATIENT ALSO REQUIRED ASSISTANCE PAIRING THE HANDSET AND COMMUNICATOR. PSS REVIEWED HOW TO PAIR THE COMMUNICATOR TO THE HANDSET. THE PATIENT COULD SUCCESSFULLY PAIR THE HANDSET TO THE COMMUNICATOR.

  Patient problems: Discomfort

  MAUDE report 20274689 ↗
• MalfunctionSep 20, 2024Vibration; Vibration

  IT WAS REPORTED BY THE PATIENT THAT THEY DIDN'T LIKE THE BUZZ IN THEIR BRAIN WHEN THE HEALTHCARE PROVIDER (HCP) CHECKED THE DEVICE. THE PATIENT SAID THEY FELT THE BUZZING WHEN THE HCP CHECKED THE SYSTEM'S INTEGRITY, WHICH STARTED "WAY BACK" WHEN THEY FIRST GOT THE DEVICE. THE PATIENT SAID THE LAST TIME THEY WENT TO THE DOCTOR, IT DIDN'T DO IT, AND IT HAD BEEN ALL THE TIMES BEFORE, AND THEY TOLD THE PATIENT IT WAS BECAUSE THEIR BRAIN DIDN'T LIKE TO BE MESSED WITH. THE PATIENT ALSO REQUIRED ASSISTANCE PAIRING THE HANDSET AND COMMUNICATOR. PSS REVIEWED HOW TO PAIR THE COMMUNICATOR TO THE HANDSET. THE PATIENT COULD SUCCESSFULLY PAIR THE HANDSET TO THE COMMUNICATOR.

  Patient problems: Discomfort

  MAUDE report 20274685 ↗
• InjurySep 19, 2024Break; High impedance; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Break; High impedance; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT REPORTED A FALL HITTING THEIR HEAD, WHICH WAS WHEN THEY NOTED A DECREASE IN EFFICACY AND OCCASIONAL SHOCK ON THE LEFT SIDE OF THE BODY. THE MD DISCOVERED IMPEDANCES OUT OF RANGE ON THE RIGHT SIDE, ALL MONOPOLES. A REVISION SURGERY WAS PERFORMED. THE LEAD, EXTENSION, AND BATTERY WERE REPLACED. UPON VISUAL INSPECTION, THE LEAD/EXTENSION CONNECTION APPEARED DAMAGED. POST-NEW IMPLANTS, IMPEDANCES WERE ALL CLEAR, AND NO SHOCKING SENSATION WAS PRESENT. LT LEAD, EXTENSION, AND BATTERY ARE STILL INTACT AND NORMAL. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE AND HAD NO INJURY AT THE TIME OF THE REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Electric Shock

  MAUDE report 20263827 ↗
• InjuryJul 5, 2024Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE EVENT OCCURRED AT HOME. THE DEVICE WAS BRIEFLY TURNED ON DURING THE CLINIC VISIT AFTER THE EVENT WITHOUT ANY ISSUES OF SHOCKING OR OTHER ADVERSE EFFECT. THE CAUSE WASN¿T DETERMINED. THE DEVICE REMAINED OFF WITHOUT STIMULATION PER THE PATIENT¿S REQUEST.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 19679945 ↗
• InjuryJul 5, 2024Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT ALL 4 CONTACTS HAD HIGH IMPEDANCES AND THE PATIENT HAS HAD NO FALLS OR TRAUMA. THE MONOPOLAR CONTACTS IMPEDANCE VALUES WERE AS FOLLOWS: CONTACT 0- 7913, CONTACT 1- 5394, CONTACT 2- 4746, AND CONTACT 3- 5394. THE BIPOLAR CONTACTS IMPEDANCE VALUES WERE AS FOLLOWS: CONTACT 0-3 7148, CONTACT 0-2 5495, CONTACT 0-1 7923, CONTACT 3-2 2327, 0-2 5495, 0-3 7148, 2-1 2602, 1-0 3747, AND 1-3 3942. THE IMPLANTABLE NEUROSTIMULATORS (INS) HAVE BEEN TURNED OFF FOR NOW. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED. NOTHING WAS DONE AT THIS TIME AND THE ISSUE HADN¿T BEEN RESOLVED.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 19679928 ↗
• MalfunctionMay 22, 2024Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM THE CONSUMER WHO REPORTED THE IMPLANTABLE NEUROSTIMULATOR DIED 2.5 WEEKS AGO OUT OF THE BLUE, AND THEY EXPECTED IT TO LAST 5 YEARS LIKE THE PREVIOUS ONE DID. THE HEALTHCARE PROVIDER (HCP) WAS ALSO SURPRISED BECAUSE THEY SEE THEM EVERY 2 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371538 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR REMOVED THE RIGHT DBS (RIGHT BATTERY, LEAD AND EXTENSION) DUE TO EXPOSED HARDWARE ON THE EXTENSION DUE TO COMBINATION OF FACTORS, INCLUDING PATIENT SCRATCHING THE EXTENSION SITE (EXTENSION VISIBLE BEHIND PATIENT'S RIGHT EAR). PATIENT'S LEFT DBS SYSTEM REMAINED IN PATIENT.

  Patient problems: Abrasion; Erosion; Itching Sensation

  MAUDE report 19370644 ↗
• InjuryMay 6, 2024Break; High impedance; Impedance Problem; Break; High impedance; Impedance Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED PRE-OPERATIVELY IMPEDANCES WERE NORMAL, BUT DURING THE BATTERY CHANGE IMPEDANCES WERE CHECKED AGAIN WHICH WERE FOUND TO BE ABNORMAL. IT WAS THEN IDENTIFIED THE LEFT EXTENSION WAS IN TWO PIECES. IT APPEARED TO BE A CLEAN SEPARATION AND APPEARED TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE AS ALL IMPEDANCES WERE NORMAL PRE-OPERATIVELY. THE EXTENSION WAS GOING TO BE REPLACED AT A LATER DATE, BUT WAS NOT YET SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247806 ↗
• InjuryApr 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE CALLER REPORTED THAT THE PATIENT FELT LIKE SOMETHING WAS NOT WORKING CORRECTLY WITH THE INS BECAUSE THEY HAVE NOT BEEN FEELING THEMSELVES AND THEY WERE HAVING "REALLY BAD SPEECH." THE CALLER WAS NOT WITH THE PATIENT AND THEY MENTIONED THAT THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE CALL, NOTING THAT THEY HAD BEEN IN THE HOSPITAL FOR THE PAST 2-3 DAYS. THE CALLER STATED THAT THEY TRIED CALLING THE MANUFACTURER REPRESENTATIVE (REP), BUT THE PHONE NUMBER WAS INACTIVE. THE CALLER ASKED IF A  REP COULD CHECK THE PATIENT'S INS WHILE THEY WERE IN THE HOSPITAL. AGENT REVIEWED THAT THE HOSPITAL COULD CALL NAS AND REQUEST TO HAVE THEIR LOCAL MDT REP PAGED. THE CALLER WAS ADVISED TO HAVE THE PATIENT FOLLOW UP WITH THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Dysphasia; Malaise

  MAUDE report 19180495 ↗

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.