Percept™ PC BrainSense™ B35200 (UDI 00763000420987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 547 adverse event reports that list this exact device (DI 00763000420987), received between Jan 20, 2021 and Sep 4, 2026 — classified as 1 death, 248 injuries, 298 malfunctions.

The most frequently reported specific device problem is “High impedance” (127 reports).

4 FDA recall records name this device's identifier, 4 still open.

18 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. 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 ↗

2. Mar 30, 2022Open, Classified

   The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

   Z-1129-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Mar 30, 2022Open, Classified

   The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

   Z-1128-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 19, 2021Open, Classified

   During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

   Z-0418-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 547 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620430 ↗
• InjuryJul 29, 2026Inappropriate/Inadequate Shock/Stimulation; Unauthorized Access to Computer System

  It was reported that patient (pt) thinks there might be something wrong with their stimulator because they had felt strong bolts of energy going through their body and it had been really scary. Patient said that this happened in the hospital maybe two months ago and said the same thing had happened maybe a couple more times. Patient was redirected to health care provider. Additional information received from healthcare provider (HCP) indicating that patient can be very confused at times. They reported to them that someone was having sexual relations with the through their DBS device. Patient was last seen in office in May where all was good with impedances and stimulation.

  Patient problems: Confusion/ Disorientation; Electric Shock

  MAUDE report 50075795 ↗
• InjuryJul 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM AN ALLIED HEALTHCARE PROFESSIONAL STATING THE PATIENT¿S NEUROSTIMULATOR HAD BEEN REMOVED WHILE THE LEADS REMAINED IMPLANTED. THE CALLER REPORTED THAT AN ACTIVE NEUROSTIMULATOR WAS PLACED ON (B)(6) 2021; HOWEVER, IMAGING FROM (B)(6) 2021 SHOWED ONLY THE LEADS REMAINING, WITH NO NEUROSTIMULATOR PRESENT AND NO EXTENSIONS APPEARING TO RUN FROM THE LEADS DOWN THE PATIENT¿S NECK. THE CALLER CONFIRMED THE LEADS WERE CAPPED AND STATED IT APPEARED THE NEUROSTIMULATOR AND EXTENSIONS WERE REMOVED DAYS FOLLOWING A NEUROSTIMULATOR REPLACEMENT. LEAD-ONLY SYSTEM MRI GUIDELINES WERE REVIEWED, AND THE CALLER WAS TRANSFERRED TO THE REPRESENTATIVE PAGING SERVICE AS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791701 ↗
• MalfunctionJun 24, 2026Premature Discharge of Battery; Inadequacy of Device Shape and/or Size; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S DBS SYSTEM HAS NOT WORKED. PATIENT REPORTED THEY WERE TOLD THE DEVICE WOULD LAST LONGER AND WAS SMALLER, BUT REPORTED ONCE IT WAS IN THEIR CHEST IT WASN'T SMALLER DIMENSIONALLY. PATIENT STATED THE ONLY THING THAT IS EVEN KIND OF COMFORTABLE IS LAYING ON THEIR SIDE AND IT IS EXTREMELY DEBILITATING RIGHT NOW AND REPORTED THEIR IMPLANT JUST DIED ON THEM OUT OF THE BLUE ON TUESDAY. PATIENT INQUIRED IF THERE IS A WAY TO EXPEDITE THE SURGERY IF THEIR SYSTEM JUST DIES. PATIENT ALSO INQUIRED ABOUT IMPLANT LONGEVITY. AGENT REVIEWED LONGEVITY OVERVIEW AND REDIRECTED PATIENT TO THEIR DOCTOR TO DISCUSS. PATIENT ALSO EXPRESSED DISSATISFACTION WITH THEIR HEALTHCARE PROVIDER AS PATIENT STATED THEIR HCP DID NOT PUT THE BATTERY IN THE RIGHT PLACE AND HIS PA DID NOT CLOSE UP THE SITE WELL. * SEE (B)(4)FOR SYMPTOMS ON INITIAL PROGRAMMING AND REP DISSATISFACTION * SEE (B)(4) FOR HISTORICAL DEVICE DISSATISFACTION.

  Patient problems: Discomfort

  MAUDE report 25608953 ↗
• MalfunctionJun 9, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT IS CURRENTLY IN CONTACT WITH THE HCP AND STATED THAT "IT DRAINED FROM 3 BARS IN A WEEK". CALLER STATED THAT THEY GOT A CRITICAL ALERT BECAUSE THE BATTERY IS DYING AND STATED THAT THE BATTERY IS DRAINING A LOT QUICKER THAN ANTICIPATED. AGENT REVIEWED INS BATTERY LONGEVITY AND REDIRECTED THEM TO THE HCP TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448225 ↗
• MalfunctionMay 21, 2026Energy Output Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING TROUBLE WALKING FOR ABOUT A MONTH AND THE HEALTHCARE PROVIDER TOLD THEM TO CALL TO SEE IF THERE IS ANYTHING THAT THEY CAN DO TO HELP WHILE THEY GET TO SEEING THE DOCTOR UNTIL JUNE. THE CALLER LAST SAW THE HCP IN SEPTEMBER AND WERE TOLD THEY HAD 8 MONTHS LEFT ON THE BATTERY. DURING THE CALL, THE CALLER WAS SEEING SERVICE CODE 1710, ERI. REVIEWED TO CONTACT THE NEUROSURGEON, BECAUSE THE PATIENT NEEDS A SURGERY TO REPLACE THE BATTERY. THE CALLER IS WONDERING IF THEY SHOULD TURN THE THERAPY DOWN TO TRY TO MAKE IT LAST LONGER OR SOMETHING. REVIEWED WITH THE CALLER THAT WE ARE NOT QUALIFIED TO RECOMMEND ANY ADJUSTMENTS AND OFFERED TO SHOW THE CALLER HOW TO USE THE REMOTE. THE CALLER DECREASED THE SETTINGS SLIGHTLY ON EACH SIDE. THE BATTERY WAS SHOWING LESS THAN 3 MONTHS. THE CALLER REPORTED THAT THE LEG WAS FEELING A LITTLE NUMB AND TINGLING, BUT NOW IT IS FEELING LOOSER AFTER DECREASING. AGENT ADVISED THE CALLER TO KEEP TRYING TO CALL THE DOCTOR AND LET THEM KNOW WHAT IS GOING ON.

  Patient problems: Ambulation or Postural Difficulties; Device Overstimulation of Tissue; Numbness; Paresthesia

  MAUDE report 25241996 ↗
• MalfunctionMay 7, 2026High impedance; Unintended Collision; Energy Output Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT  THE PATIENT HAD A FALL ON THE 17TH OF APRIL AND NOTICED A CHANGE IN THERAPY AFTER THAT. CALLER STATED THE PATIENT HAD TO INCREASE THEIR MEDICATION, KEPT GETTING ERROR CODES ON THEIR PROGRAMMER SAYING "OUT OF RANGE" AND COULDN'T ADJUST STIM BUT IS STILL GETTING STIM ON ONE SIDE. CALLER MET THE PATIENT TODAY IN THE OFFICE AND HIGH IMPEDANCES WERE DISCOVERED ON THE LEFT STN. CALLER PROVIDED IMPEDANCE MEASUREMENTS FOR MONOPOLAR CONTACTS 8-10 WERE GREATER THAN 5K OHMS AND CONTACT 11 WAS 3768 OHMS. ALL BIPOLAR PAIRS WERE GREATER THAN 10K OHMS. CALLER STATED THAT WHEN PATIENT FELL, THEY OUTSTRETCHED THEIR ARM TO BREAK THEIR FALL SO ISSUE MAY BE WITH EXTENSION AS OPPOSED TO LEAD. AGENT SUGGESTED IMAGING AND INTRA-OP TESTING OF THE LEAD TO DETERMINE WHICH COMPONENT HAS THE IMPEDANCE ISSUES. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Fall

  MAUDE report 25113353 ↗
• MalfunctionApr 27, 2026Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT PATIENT HAD A GOOD SHOCK AT WORK AS AN ELECTRICIAN ABOUT 2.5 - 3 MONTHS AGO THAT CAUSED A RETURN OF SYMPTOMS AND TICS. PATIENT WAS STILL ABLE TO WORK. PATIENT ALSO EXPERIENCE WEAKNESS AND NUMBNESS ON LEFT SIDE OF BODY THAT HAS BEEN PROGRESSING. PATIENT WENT TO HOSPITAL ON SATURDAY AND WAS TRANSFERRED TO (B)(6). MRI TO BE DONE FOR POSSIBLE STROKE. CALLER MET WITH PATIENT ON (B)(6) AND MADE SOME PROGRAMMING CHANGES THAT HELPED WITH THE TICS BUT NOT THE WEAKNESS AND NUMBNESS. CALLER REPORTED ONE OF PATIENT'S TICS IS PUNCHING HIS NECK WHERE THE EXTENSION IS BUT CALLER CHECKED THE SYSTEM INTEGRITY AND NO ISSUES REPORTED. ADDITIONAL INFORMATION RECEIVED FROM REP CLARIFYING THAT PATIENT WENT TO HOSPITAL FOR RIGHT SIDED WEAKNESS AND NUMBNESS, MRI SHOWED NO SIGN OF STROKE PER HCP. IT IS UNKNOWN IF MANUFACTURER DEVICE IS CAUSAL OR CONTRIBUTORY TO THESE SYMPTOMS. PATIENT WAS ORIGINALLY SHOCKED ON THE JOB DUE TO TOUCHING A LIVE OUTLET WHILE WORKING ON THEIR JOBSITE UNRELATED TO THEIR DBS SYSTEM. THE EXACT DATE OF THIS SHOCK IS UNKNOWN BUT PATIENT REPORTS THAT IT WAS A COUPLE MONTHS AGO. SYMPTOMS REMAIN ONGOING.

  Patient problems: Discomfort; Muscle Weakness/Atrophy; Numbness; Tics/Tremor

  MAUDE report 25005116 ↗
• MalfunctionApr 21, 2026High impedance

  REP CONFIRMS THAT THIS WAS DISCOVERED DURING A REGULAR DEVICE CHECK UP. ADDITIONAL INFORMATION RECEIVED WHERE REPRESENTATIVE MENTIONED THEY JUST DID A BATTERY CHANGE FROM PRIMARY CELL TO RECHARGEABLE CELL AND EVERYTHING LOOKED GOOD IN TERMS OF CONNECTIVITY AND IMPEDANCES, BUT THEN THE HCP WENT TO CLOSE AND THE CONNECTIVITY TEST SUDDENLY SHOWED A LACK OF CONNECTIVITY. REP. SAID THEY HAD RUN THE IMPEDANCE TEST AGAIN AND EVERYTHING LOOKED GOOD EXCEPT FOR CONTACT 11, REP RAN THE IMPEDANCE TEST AGAIN AND SAW THE IMPLANTABLE NEUROSTIMULATOR (INS) NOW HAD SOME IMPEDANCE RESULTS THAT WERE ELEVATED. CONTACT 11 HAD 38,000(MONOPOLAR) OHMS. CONTACT 10 A-C HAD IMPEDANCE OVER 10,000 OHMS. REP. SAID LEFT GPI MONOPOLARS ARE ALL GOOD, BUT NOW, 2C AND 2B AND 2A AND 2B ARE AT 10,000. REP. SAID THE "THEY WERE NOT LIKE THAT, BUT THE MORE THEY RUN IMPEDANCE, THE MORE IMPEDANCE ISSUES COME UP. FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED BECAUSE HCP HAD ALREADY CLOSED. TECH SERVICES ASKED WHAT SOLUTION HAD BEEN USED FOR POCKET CLEANING AND REP. SAID AN ANTIBIOTIC SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948310 ↗
• MalfunctionApr 8, 2026High impedance

  IT WAS REPORTED THAT DURING ELECTIVE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS), ELEVATED IMPEDANCES WERE IDENTIFIED ON THE RIGHT SIDE CONTACTS 1, 2, AND 3. IMPEDANCE TESTING WAS PERFORMED AT THE HIGHEST VOLTAGE. IMPEDANCES REMAINED ELEVATED WITH THE NEW GENERATOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816390 ↗
• MalfunctionMar 25, 2026Battery Problem

  IT WAS REPORTED THAT CLINICIAN ASKING IF THIS NORMAL BATTERY DRAIN WITH BRAINSENSING STARTED. (B)(6) 2025 BATTERY LONGEVITY 1 YEAR 7 MONTHS (0.1MA INCREASE BILATERALLY). END OF (B)(6) 2025 BATTERY LONGEVITY 12 MONTHS - BRAINSENSE RECORDING STARTED (B)(6) 2026 BATTERY LONGEVITY 6 MOS. CLINICIAN CONCERNED WITH LONGEVITY DROP WITH SENSING. SENSING STOPPED UNTIL BATTERY RX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691490 ↗
• MalfunctionMar 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE CAUSE OF THE INCONSISTENT BATTERY LIFE IS UNKNOWN, WITH A POSSIBLE SOFTWARE ISSUE CONSIDERED BUT NOT CONFIRMED. STEPS TAKEN INCLUDE REPORTING THE ISSUE AND SHARING PATIENT SESSION REPORTS WITH TECHNICAL TEAMS. THE ISSUE HAS NOT BEEN RESOLVED, IT IS UNCLEAR WHETHER NORMAL BATTERY DEPLETION WAS A FACTOR, AND THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677015 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE 5 YEARS AGO (HEALTHCARE PROVIDER (HCP) DID NOT GIVE AN EXACT DATE) AND THE SURGEON DECIDED TO REMOVE THE ENTIRE DBS SYSTEM AT THAT TIME. NO MANUFACTURER REPRESENTATIVE (REP) WAS MADE AWARE OF THIS AT THAT TIME. REP WAS NOTIFIED AT THE SURGERY TO REPLACE THE 2 BRAIN LEADS ON (B)(6) 2026. REP SAYS THE INFECTION HAS BEEN RESOLVED BY THE TIME OF THE REPORT. REP INDICATED THAT THE SYSTEM WAS DISCARDED AFTER REMOVAL. REP INDICATED THAT THE EXPLANT DATE WILL NOT BE MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24537112 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A LACK OF EFFICACY OF THE IMPLANTED SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED, AND THE ENTIRE SYSTEM WAS REMOVED. A FULL SYSTEM REPLACEMENT WAS SUBSEQUENTLY CONDUCTED, WITH A NEW SYSTEM IMPLANTED TARGETING A DIFFERENT AREA.

  Patient problems: Insufficient Information

  MAUDE report 24390875 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A LACK OF EFFICACY OF THE IMPLANTED SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED, AND THE ENTIRE SYSTEM WAS REMOVED. A FULL SYSTEM REPLACEMENT WAS SUBSEQUENTLY CONDUCTED, WITH A NEW SYSTEM IMPLANTED TARGETING A DIFFERENT AREA.

  Patient problems: Insufficient Information

  MAUDE report 24390839 ↗
• MalfunctionFeb 18, 2026Electromagnetic Interference; Failure to Deliver Energy; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (PT) HAD AN MRI ABOUT 6 WEEKS AGO AND AFTER THE MRI THEY NOTICED SOMETHING WAS DIFFERENT, "THEY TOOK SOMETHING OUT OF THEIR DBS AND NEED TO GET IT REPLACED". AGENT ASKED HOW THINGS WERE DIFFERENT AND PT SAID THEY DID NOT KNOW. AGENT ASKED IF PT WAS ABLE TO GET THERAPY BACK ON AFTER THE MRI AND PT SAID NO. AGENT ASKED IF PT WOULD LIKE TO USE THEIR EQUIPMENT TO TURN THERAPY BACK ON AND PT SAID THEY ARE IN A REHAB CARE FACILITY AND DOES NOT HAVE THEIR EQUIPMENT WITH THEM. AGENT ASKED IF PT HAD ANYONE WHO COULD BRING IT TO THEM AND PT DID NOT RESPOND. REVIEWED THE OPTION FOR REP/DOCTOR INVOLVEMENT AND SUPPORT. PT REQUESTED TO BE IN TOUCH WITH A REP. OFFERED AND SENT EMAIL TO THE REPS IN THE AREA. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377471 ↗
• MalfunctionFeb 16, 2026Break; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THIS INCLUDED PATIENT SAID THEY WENT TO THEIR HEAL THCARE PROVIDER AND THEY TOLD THE PATIENT THAT THEY HAD A LEAD THAT WAS BROKEN OR PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349612 ↗
• InjuryFeb 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN UPCOMING MRI APPOINTMENT SO PATIENT SERVICES REVIEWED MRI COMPATIBILITY CONSIDERATIONS AND MRI MODE WITH THE CALLER. CALLER SAID THEY WOULD REACH OUT TO THE PATIENT'S HEALTHCARE PROVIDER ABOUT POTENTIALLY GETTING AN MRI REPORT. CALLER ALSO REPORTED THE PATIENT'S RELEVANT MEDICAL HISTORY AND REPORTED THE PATIENT HADN'T EVER BEEN ABLE TO GET AN MRI WITH THEIR FIRST SYSTEM BECAUSE THE "WIRE" HAD BEEN BROKEN. CALLER STATED THE PATIENT'S HCP HAD DISCOVERED THE ISSUE SHORTLY AFTER THE PATIENT WAS IMPLANTED AND STATED THE CONNECTION HAD JUST BEEN NOT RIGHT AND THE HCP DIDN'T WANT TO GO IN TO FIX IT SO SOON, SO THE PATIENT JUST HAD TO "LIVE WITH IT" AND HADN'T BEEN ABLE TO GET AN MRI. CALLER STATED THE HCP HAD TO DO WORK AROUNDS TO PROGRAM THE PATIENT'S THERAPY SETTINGS AND THE PATIENT HAD TROUBLE WITH THEIR DYSKINESIA BECAUSE OF IT BUT THEN THEY REPLACED THE BATTERY AND FIXED THE ISSUE ON (B)(6) 2025 AND THEN THE CALLER WAS TOLD BY THE PATIENT'S TEAM THAT WITH THE REPLACEMENT, THE PATIENT WAS NOW ABLE TO GET AN MRI. CALLER AND PATIENT TO FOLLOW UP WITH THE PATIENT'S HCP TO REQUEST A POTENTIAL MRI REPORT. THEY MAY CALL BACK FOR FURTHER ASSISTANCE ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246315 ↗
• MalfunctionJan 6, 2026Energy Output Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. PATIENT ALSO MENTIONED THEY NEEDED AN MRI BECAUSE THEIR LEG HURTS AND WERE TOLD THAT THEY NEEDED TO HAVE AN IMPEDANCE CHECK BY A NEUROLOGIST, BUT THEY COULD NOT SET THE SCHEDULE WITH THEIR CURRENT NEUROLOGIST. DURING THE CALL, PATIENT ALSO MENTIONED THAT THEY REALIZED THEY HAD THE WRONG THERAPY ON AND THAT'S WHY THEY DO NOT FEEL RIGHT AND THAT WAS THEIR FAULT. PATIENT STATED THEY HAD THE THERAPY THAT WAS STRONG. AGENT OFFERED PHYSICIAN LISTINGS. AGENT SENT PATIENT AN EMAIL WITH PHYSICIAN LISTINGS AND SENT REQUEST TO REPAIR TO REPLACE THE HANDSET. CALLS AGENT REACHED OUT TO HCIT TO CONFIRM RESOLUTION. PATIENT HAS THE SAME DOCTOR ON FILE, UNABLE TO PULL PATIENT HCP FROM DROP DOWN.

  Patient problems: Pain

  MAUDE report 23971136 ↗
• MalfunctionDec 11, 2025Electromagnetic Compatibility Problem; Data Problem; Electromagnetic Compatibility Problem; Data Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT CAUSE WAS USER ERROR AND THE REPORTED EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778763 ↗
• 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 HEALTHCARE PROVIDER (HCP) AND THE HCP WROTE: THE PATIENT (PT) WAS HOSPITALIZED FOR A SEIZURE RECENTLY. WHEN THEY CHECKED THEIR DEVICE A RED OUTLINED ERROR SCENE POPPED UP SAYING THERE WAS AN UPDATE. HCP UPDATED THE DEVICE AND ALL IS WELL. WHEN HCP CHECKED THE LOGS IT SAYS THE STIMULATOR HAS BEEN ON THE WHOLE TIME. HCP ASKED IF THAT WOULD RESET WITH THE UPDATE, OR SHOULD THEY ASSUME IT'S BEEN ON THE WHOLE TIME? HCP ASKED BECAUSE PT BATTERY IS ESTIMATED TO HAVE 11 MONTHS LEFT. BUT THAT WOULD BE BASED ON RECENT USE - SO COULD BE INACCURATE IF THE MACHINE HAS BEEN OFF FOR A WHILE. HCP ASKED IF REP WOULD HAVE ACCESS TO ANY BETTER INFO FROM THE BATTERY? THEY WOULDN'T BE ABLE TO TELL ME IF IT HAD BEEN OFF CLINICALLY (VERY ADVANCED PD)" THE CALLER DOES NOT KNOW WHAT THE RED ERROR WAS OR DETAILS AROUND THE ISSUE BEYOND WHAT WAS PRESENTED HERE. AGENT REVIEWED OPTIONS AND CONSIDERATIONS FOR THE CALLER AND EMPHASIZED THAT ANY THERAPY ON/OFF INDICATORS WOULD BE CLEAR IN THE CLINICIAN TABLET AND IF THE DIARIES SHOWED THE IMPLANTABLE NEUROSTIMULATOR (INS) ON WE WOULD NOT PRESUME IT WAS NOT ON. AGENT REVIEWED PULLING LOGS/FILES/DATA AS A PO

  Patient problems: Convulsion/Seizure

  MAUDE report 23770160 ↗
• InjuryNov 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT STATED THAT THEY ARE SUPPOSED TO HAVE SURGERY ON THE (B)(6) OF OCTOBER TO REPLACE THEIR IMPLANT. PATIENT STATED THAT THIS WILL BE THE 2ND REPLACEMENT THEY HAVE HAD. PATIENT SAID THAT THEY HAD THE FIRST BATTERY REPLACED AND NOW IT'S TIME FOR THE 3RD ONE. PATIENT ASKED ABOUT THE DIFFERENCE BETWEEN A RECHARGEABLE AND NON-RECHARGEABLE IMPLANT. AGENT REVIEWED INFORMATION WITH THE PATIENT. CALLER STATED THAT THEY FEEL LIKE THE IMPLANT IS RUNNING DOWN FAST BUT THEY WERE AWARE THAT BATTERY LIFE IS DEPENDENT ON SETTINGS. CALLER ALSO MENTIONED THAT THEY ARE STILL HAVING LEVODOPA/CARBIDOPA BUT FEEL LIKE THE MEDICATION WEARS OFF SOONER THAN IT USED IT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450936 ↗
• InjuryNov 3, 2025Break; Low impedance; Break; Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE SURGEON SAID IT WAS A PROBLEM WITH THE EXTENSIONS. SURGEON SAID HE THINKS THE EXTENSION WAS DAMAGED, POSSIBLY DUE TO THE TIGHTNESS/BOWSTRINGING THAT WAS SEEN. ISSUE IS RESOLVED.

  Patient problems: Adhesion(s)

  MAUDE report 23450845 ↗
• MalfunctionOct 21, 2025Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT REPORTED THAT 1 OF THE PARTS WAS NOT CHARGED. PATIENT CLARIFIED THAT THE RECHARGER WAS NOT USED FOR 4+ YEARS AND HAD BEEN SITTING UNUSED. PATIENT REPORTED THAT ISSUE HAS BEEN RESOLVED AFTER MEETING WITH MANUFACTURING REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348849 ↗
• MalfunctionOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT BENT DOWNWARDS TO GRAB SOMETHING AND HEARD A LITTLE CLICK. CALLER STATES IT LOOKS LIKE THE IMPLANT IS A LITTLE FURTHER OUT. CALLER IS WONDERING IF THEY SHOULD TAKE THE PATIENT TO THE EMERGENCY ROOM. AGENT ASKED CALLER TO CONNECT TO THE IMPLANT AND CALLER WAS ABLE TO CONNECT. PATIENT STATED THEY FEEL LIKE THEY CAN'T MOVE THEIR NECK AND LIKE SOMETHING IS PULLING. AGENT REVIEWED ROLE OF PATIENT SERVICES AND ADVISED CALLER TO SEEK MEDICAL CARE IF THEY ARE CONCERNED WITH SITUATION. CALLER STATED THEY TRIED TO GET A HOLD OF HEALTH CARE PROVIDER BUT COULDN'T GET THROUGH.

  Patient problems: Insufficient Information; Neck Stiffness

  MAUDE report 23300266 ↗

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-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
• Z-0187-2009 · Jun 14, 2008 · Terminated
  Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Th
• Z-0185-2009 · Jun 14, 2008 · Terminated
  Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide

…and 3 more.