Percept™ PC BrainSense™ B35200 (UDI 00763000253363)Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 00763000253363), received between Jul 16, 2020 and Sep 28, 2026 — classified as 1 death, 131 injuries, 148 malfunctions.

The most frequently reported specific device problem is “High impedance” (67 reports).

3 FDA recall records name this device's identifier, 2 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. 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 ↗

2. 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 ↗

3. Nov 19, 2020Terminated

   A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

   Z-0612-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Electromagnetic Interference; Energy Output Problem

  Patient problems: Convulsion/Seizure

  MAUDE report 50914832 ↗
• MalfunctionMay 11, 2026Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEW DAYS AGO THEY HAD TO TURN THEIR THERAPY OFF FOR AN EKG , AND SINCE TURNING THE DEVICE BACK ON THE HAVE BEEN FEELING " WAVES " THROUGH THEIR BODY. CALLER STATED THAT THEY DON'T FEEL LIKE THEIR SETTINGS ARE WRONG. AGENT WALKED THE CALLER THROUGH THE STEPS OF CONNECTING TO THE DBS THERAPY APP. WHEN THE CALLER CONNECTED TO THE APP THEY DID NOT HAVE ACCESS TO ADJUST THEIR STIM. CALLER WAS REDIRECTED TO THE HEALTHCARE PROVIDER (HCP) TO FURTHER ASSIST.

  Patient problems: Insufficient Information

  MAUDE report 25143168 ↗
• MalfunctionApr 3, 2026Unintended Collision; Low impedance

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE CAUSE OF THE LOW IMPEDANCE WAS NOT DETERMINED, THOUGH THE PHYSICIAN SUSPECTED IT MAY BE RELATED TO A PATIENT FALL. THE PHYSICIAN ADJUSTED THE PROGRAMMING TO USE UNAFFECTED ELECTRODES; THE ISSUE HAS NOT BEEN RESOLVED, AND NO FURTHER ACTION IS PLANNED. THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.

  Patient problems: Shaking/Tremors

  MAUDE report 24781546 ↗
• InjuryMar 30, 2026Failure to Deliver Energy; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). HCP REPORTED THAT DEVICE WAS REPLACED ON 2026-APRIL-23.

  Patient problems: Bronchopneumonia; Dysphagia/ Odynophagia

  MAUDE report 24715478 ↗
• MalfunctionFeb 3, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT HAS ABNORMAL IMPEDANCES ON ONE OF HIS LEADS. CALLER REPORTS THEY ARE TRYING TO SET UP BRAIN SENSING FOR THE PATIENT BUT ARE NOT ABLE TO DUE TO THE HIGH IMPEDANCE. CALLER IS WONDERING IF THEY CAN DO ADAPTIVE PROGRAMMING ON ONE SIDE OF THE PATIENT. TECHNICAL SERVICE SPECIALIST REVIEWED THAT IT IS POSSIBLE TO DO SO ON ONE HEMISPHERE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THIS STARTED AWHILE AGO AND WAS DOCUMENTED IN (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249885 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEAD TO EXTENSION CONNECTION INCISION CAME OPEN AFTER REVISION. THE SYSTEM THEN BECAME INFECTED. HEALTHCARE PROVIDER (HCP) ATTEMPTED TO USE ANTIBIOTICS BUT THAT DID NOT RESOLVE THE INFECTION SO THE SYSTEM WAS EXPLANTED AND THIS RESOLVED THE ISSUE. MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE SYSTEM WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24223161 ↗
• InjuryJan 9, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT REPORTED EXPERIENCING A SEIZURE ON (B)(6) (YEAR NOT CONFIRMED), STATING THAT THEY DIED AS A RESULT OF THE EVENT, RECEIVED CPR, AND WERE SUBSEQUENTLY REVIVED. THE PATIENT STATED THAT SINCE THIS INCIDENT, THEIR IMPLANT HAS MOVED, WHICH THEY BELIEVE LED TO EXTENSIVE BRUISING. THE PATIENT ATTRIBUTED THE BRUISING TO BROKEN BLOOD VESSELS, EXPLAINING THAT THE IMPLANT WIRES WERE CLOSE TO THE CAROTID ARTERY AND MAY HAVE BEEN DAMAGED DURING CPR. THE PATIENT FURTHER REPORTED THAT THEY HAD ALREADY FOLLOWED UP WITH THEIR HCP, WHO ADVISED THAT THE IMPLANT WAS FUNCTIONING PROPERLY. THE PATIENT ALSO STATED THAT THEY WERE NOT RECEIVING PARKINSON¿S DISEASE MEDICATIONS CONSISTENTLY. THE AGENT REVIEWED GENERAL THERAPY INFORMATION AND THE ROLE OF PATIENT SERVICES, AND REDIRECTED THE PATIENT TO THEIR HCP FOR FURTHER EVALUATION. BEFORE ADDITIONAL INFORMATION COULD BE REVIEWED, THE PATIENT BECAME DISTRAUGHT AND INTENTIONALLY DISCONNECTED THE CALL.

  Patient problems: Bruise/Contusion; Cardiac Arrest; Convulsion/Seizure

  MAUDE report 24017536 ↗
• MalfunctionDec 18, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE, INDICATING THERE IS NO KNOWN REASON FOR THE IMPEDANCE ISSUE; THE LEAD WAS IMPLANTED YEARS AGO BUT WAS NEVER ACTIVATED, AND THE PHYSICIAN BELIEVES PROLONGED INACTIVITY MAY BE A FACTOR; ONE CONTACT WITH NORMAL IMPEDANCE WAS IDENTIFIED AND PROGRAMMED, AND THE PATIENT DERIVED BENEFIT FROM THAT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838536 ↗
• InjuryNov 28, 2025Energy Output Problem; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD TO HAVE CPR ON JUNE 26TH AND BY JULY THEY STARTED SEEING A REDNESS IN THE AREA AND BY AUGUST IT STARTED PUFFING UP ALMOST LIKE SWELLING AND IT LOOKS LIKE THEY HAVE A 3RD BOOB GROWING, THEY CAN SEE THE SHAPE OF THE BATTERY IN THE PUFFED UP AREA, THEY CAN ALSO SEE THE WIRES ALMOST LIKE IT IS GOING TO BURST THROUGH THEIR SKIN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT ALSO REPORTED: BECAUSE OF THEIR PARKINSON'S THEY ARE GETTING A LOT OF CRAMPING, SHOCKING THAT RUNS THROUGH THEIR BODY THAT THEY HAVE NEVER HAD BEFORE AND THEY ARE WONDERING IF THIS THING IS FLOATING AROUND AND BREAKING BLOOD VESSELS AND GIVING THEM SHOCKS THAT ARE GOING THROUGH THEIR LEGS, THEY DID NOT HAVE THAT BEFORE AND IT IS BEING DONE ON THEIR RIGHT SIDE AND THE RIGHT SIDE IS NOT CONTROLLED BY THE DBS JUST THE LEFT SIDE. PATIENT ASKED: COULD THE COMPONENTS OF THE IMPLANTED SYSTEM BREAK LOOSE FROM WHERE THEY ARE SPECIFICALLY IMPLANTED. REVIEWED INFORMATION ABOUT ADVERSE EVENTS. PATIENT REPORTED THEY ARE IN A NURSING HOME NOW BECAUSE THEY CAN'T FUNCTION PROPERLY BECAUSE OF THIS AND THEY WOULD LIKE TO GET AWAY FROM CURRENT HCP. OFF

  Patient problems: Cramp(s) /Muscle Spasm(s); Electric Shock; Erosion; Erythema; Insufficient Information; Swelling/ Edema

  MAUDE report 23672055 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S STIMULATOR WAS REMOVED APPROXIMATELY FOUR MONTHS AGO DUE TO COMPLICATIONS. THE PATIENT INITIALLY EXPERIENCED A SKIN BREAK ON THE HEAD, WHICH LED TO AN INFECTION THAT WAS TREATED AND CLOSED. ABOUT A MONTH LATER, FURTHER ISSUES AROSE, AND AN INFECTION WAS DISCOVERED ON THE LEAD WIRES. THIS PROMPTED THE DECISION TO REMOVE THE ENTIRE SYSTEM. THE ISSUE REPORTEDLY BEGAN AT LEAST SIX MONTHS AGO, POSSIBLY IN 2024. FOLLOWING THE REMOVAL, THE DOCTOR WAS ABLE TO IDENTIFY AND TREAT THE AREA AFFECTING THE PATIENT¿S RIGHT HAND, RESULTING IN IMPROVED FUNCTION. THE PATIENT STATED THAT MEDICATION IS NOW HELPING MANAGE SYMPTOMS IN THEIR LEFT HAND.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 22573158 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SWELLING OCCURRED AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE FOR AN UNKNOWN REASON. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE ISSUE. AS A RESULT, EXTENSIONS AND THE IMPLANTABLE PULSE GENERATOR WERE EXPLANTED, AND THE EXPLANTED COMPONENTS WERE SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT FOR FURTHER ANALYSIS. THE ISSUE WAS REPORTED AS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT THE CAUSE OF SWELLING WAS POSSIBLE INFECTION. REP REPORTED THAT DEVICE WAS NOT RELATED TO INFECTION.

  Patient problems: Swelling/ Edema

  MAUDE report 22482354 ↗
• MalfunctionJul 9, 2025Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) WAS "ACTING UP" FOR APPROXIMATELY A WEEK. THE PATIENT EXPERIENCED LEFT LEG SHAKING, NUMBNESS, AN ELECTRICAL SHOCK SENSATION IN THE ARM, INVOLUNTARY ARM MOVEMENTS WITH LOSS OF CONTROL, RIGHT SIDE SHAKING, AND VOICE HESITATION OR SPASMING. THE POSSIBILITY OF A DEPLETED IMPLANTABLE NEUROSTIMULATOR WAS REVIEWED, AND THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dysphasia; Electric Shock; Numbness; Shaking/Tremors

  MAUDE report 22463023 ↗
• InjuryJul 8, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THE HCP HAS HAD PATIENTS WITH EXTENSIONS ISSUES.

  Patient problems: Electric Shock; Erythema; Insufficient Information; Purulent Discharge; Shaking/Tremors; Unspecified Infection

  MAUDE report 22437501 ↗
• InjuryJun 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THEIR DBS THERAPY HAS NOT WORKED FOR THEM SINCE THE IMPLANT AND HAS NOT HELPED ALLEVIATE THEIR SYMPTOMS. THE PATIENT SAW THE DOCTOR THE DAY AFTER SURGERY AND WAS TOLD DBS WAS NOT WORKING. THE PATIENT MENTIONED SEEING MULTIPLE HEALTHCARE PROVIDERS BECAUSE OF THE DBS, AND NONE OF THEM WERE ABLE TO ADJUST THE PROGRAMMING EFFECTIVELY. THE PATIENT STATED THEY REGULARLY VISIT A MANUFACTURER REPRESENTATIVE FOR ADJUSTMENTS, BUT DESPITE ATTEMPTS TO MODIFY THE SETTINGS, THE THERAPY HAS NOT BEEN BENEFICIAL. THE PATIENT ALSO NOTED THAT THEY ARE SCHEDULED FOR A BATTERY REPLACEMENT NEXT MONTH, HAVE AN UPCOMING APPOINTMENT, AND WOULD LIKE TO UNDERSTAND THEIR ELIGIBILITY FOR THE NEW DBS ADAPTIVE THERAPY SOFTWARE. THE AGENT REVIEWED INFORMATION ABOUT ADBS THERAPY AND REDIRECTED THE PATIENT TO THEIR HEALTHCARE PROVIDER. ADDITIONALLY, THE PATIENT SHARED THAT THEY HAVE UNDERGONE THREE SURGERIES FOR THE IMPLANTED NEUROSTIMULATOR SYSTEM (PERCEPT).

  Patient problems: Insufficient Information

  MAUDE report 22342832 ↗
• InjuryJun 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR WAS REMOVED. THE PATIENT MAY HAVE EXPERIENCED CONFUSION, WITH A POSSIBLE MENTAL STATUS CHANGE.

  Patient problems: Cognitive Changes; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22246161 ↗
• MalfunctionMay 23, 2025Failure to Interrogate; Communication or Transmission Problem; Electromagnetic Compatibility Problem; Failure to Interrogate; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  INFORMATION RECEIVED FROM PATIENT AND MENTIONED THE DEVICES WERE INTERFERING SO THEY PUT ONE DEVICE AT ONE END OF THE HOUSE AND THE OTHER AT THE OTHER END AND THE SCS COMMUNICATOR STILL WENT DEAD. ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT AND MENTIONED THAT THEY THINK THE DBS AND SCS ARE NOW INTERFERING BECAUSE THEY GET NOT FOUND WHEN TRYING TO CONNECT TO ONE DEVICE AND THE OTHER IS ALSO ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077253 ↗
• MalfunctionApr 4, 2025Unintended Collision; Positioning Problem; Unintended Collision; Positioning Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THAT THE AREA AROUND THEIR IMPLANT IN THEIR CHEST HAD BEEN GIVING THEM PAIN FOR THE LAST COUPLE YEARS. PATIENT SAID THAT THE IMPLANT ITSELF FELT FLATTER AND DIFFERENT THAN IT USED TO. PATIENT SAID THEY WERE A "THOUSAND TIMES WORSE" SYMPTOM WISE THAN THEY WERE WHEN THEY FIRST GOT THE DBS, PT SAID THIS STARTED HAPPENING WITHIN A YEAR OF THE DBS BEING IMPLANTED. PATIENT WAS WONDERING IF THE IMPLANTED DEVICE COULD LEAK OR IF THE MATERIALS IN THE IMPLANT COULD BE CAUSING THE ISSUE. PATIENT SAID THEY HAD FALLEN IN THE LAST COUPLE YEARS. AGENT REVIEWED INFORMATION AND REDIRECTED PATIENT TO HEALTHCARE PROVIDER. PATIENT SAID THEY WANT THE DBS SYSTEM REMOVED BECAUSE IT DOESN'T WORK BUT THE VA INSURANCE DENIED REMOVAL. PATIENT COMPLAINED TO THEIR SURGEON BUT THEY HAVE NEVER HEARD BACK FROM THEIR SURGEON. PATIENT SAID THEY HAVE AN APPOINTMENT WITH MANAGING HEALTHCARE PROVIDER IN APRIL AND WAS TOLD THAT A MANUFACTURING REPRESENTATIVE WOULD BE COMING TO THE APPOINTMENT. PATIENT MENTIONED THE ONLY TIME THEY SAW A MANUFACTURING REPRESENTATIVE WAS WHEN THEIR CONTROLLER WAS

  Patient problems: Insufficient Information; Pain

  MAUDE report 21777755 ↗
• MalfunctionMar 31, 2025Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE (PT REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. PT REP SAID LAST TIME PATIENT HAD AN EKG THE DEVICE WAS ON AND THE RESULTS WERE REALLY FUZZY. THEY WERE GETTING A LOT OF INTERFERENCE. THE PATIENT REP HAD TO GO HOME AND GET THE REMOTE TO TURN THE THERAPY OFF. THE ISSUE WAS PROBABLY A YEAR AGO. SEE (B)(4) FOR REPORT OF THERAPY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733305 ↗
• InjuryJan 16, 2025Break; High impedance; Break; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT THEY WERE RECENTLY NOTIFIED THAT PATIENT WILL BE EXPLANTED ON (B)(6) 2025 AND WILL BE RE-IMPLANTED THE FOLLOWING DAY. INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP). REP STATES THE REASON FOR THE REVISION WAS THE PATIENT WAS HAVING AN IMPEDANCE ISSUE ON ONE OF THE LEGACY LEADS BIPOLAR 10/11. THE EXTENSION REVISION WAS DONE (B)(6) 2025 TO SEE IF THAT RESOLVED THE ISSUE BUT IT DID NOT. THE PATIENT'S EXTENSIONS AND LEADS WERE COMPLETELY EXPLANTED TODAY AND WHAT REMAINS TODAY IS THE INS AND TWO EXTENSIONS THAT ARE CAPPED--THE LEADS ARE TO BE PLACED TOMORROW. THE CALLER NOTED THAT THERE WERE NO ISSUES WITH THE OTHER LEAD THAT WAS EXPLANTED (THE LEAD THAT DID NOT HAVE THE 10/11 IMPEDANCE ISSUE) BUT THE DECISION WAS TO EXPLANT EVERYTHING TODAY TO MOVE TO THE DIRECTIONAL LEADS. THE REASON FOR THE CALL WAS THEY WANT TO DO AN MRI BUT THE MRI FACILITY IS PUSHING BACK ON PURSUING THIS MRI DUE TO NO LEADS BEING PRESENT. AGENT REVIEWED GUIDELINES AND NOTED THERE IS NOTHING IN THE GUIDELINES THAT WOULD EXPLICITLY ALLOW FOR AN MRI TO BE DONE WITH ONLY THE IMPLANT AND TWO CAPPED EXTE

  Patient problems: Shaking/Tremors

  MAUDE report 21168597 ↗
• MalfunctionJan 6, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO REPORTED ABOUT 3-6 MONTHS AGO THEY HAD A SHOCK WITHIN THEIR BODY NEAR THEIR HEART AND OTHER PARTS OF THEIR BODY DURING NORMAL DAY TO DAY ACTIVITIES. ACCORDING TO THE PATIENT IT WAS A LOW-LEVEL ELECTRICAL SHOCK THAT HAPPENED MAYBE 10-20 TIMES. THE PATIENT WAS SUPPOSED TO GET AN MRI, BUT BECAUSE OF THE SHOCK THEY WOULDN¿T DO THE MRI. THERE WERE NO RECENT FALLS. THE ISSUE WAS NOT RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 21083183 ↗
• MalfunctionDec 16, 2024Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED WHO WANTED TO KNOW IF IT WAS POSSIBLE TO ACTIVATE MRI MODE WITH AN OUT-OF-RANGE ELECTRODE. THE PATIENT¿S HANDSET ALLOWED THEM TO SUCCESSFULLY ACTIVATE MRI MODE, BUT THE CLINICIAN TABLET DIDN'T DUE TO AN ELEVATED IMPEDANCE VALUE OF 2,020 OHMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20937712 ↗
• MalfunctionDec 2, 2024High impedance; High impedance

  IT WAS REPORTED THAT ON THE LEFT CONTACT 0, THERE IS AN OPEN CIRCUIT. THERE ARE NO KNOWN FACTORS THAT MAY HAVE LED TO THIS ISSUE. NO INTERVENTIONS WERE TAKEN. OPEN CIRCUIT WAS STABLE ON REPEAT TESTS. NO FURTHER ACTIONS WERE TAKEN. ADDITIONAL INFORMATION WAS RECEIVED ON 2024-NOV-25TH, REPORTING THAT IMPEDANCE WAS FLAGGED FOR REVIEW. IT WAS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT AND UNKNOWN IF ANY ACTIONS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819826 ↗
• InjuryNov 22, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS TO REPORT THAT THE COMMUNICATOR WON'T POWER WHICH WAS FIRST NOTICED A COUPLE OF DAYS AGO. WHEN ASKED, CALLER SAID THAT THE LAST TIME USED COMMUNICATOR WAS WHEN PATIENT HAD REVISION. CALLER SAID THAT PATIENT HAD A REVISION SURGERY IN (B)(6) 2024 TO HAVE THE NEUROSTIMULATOR MOVED AS IT HAD MOVED UP ON TOP OF THE COLLARBONE. CONSUMER CONFIRMED THAT PATIENT DID NOT HAVE ANY FALLS OR TRAUMA PRIOR TO THE REVISION SURGERY. CONSUMER PLUGGED IN THE CHARGING CORD AND THE GREEN LIGHT FLASHED A FEW TIMES AND THEN CUT OFF. WHEN UNPLUGGED AND PLUGGED BACK IN, NO LIGHTS CAME ON. CONSUMER RESET AND THEN TRIED TO TURN COMMUNICATOR ONE WHEN PLUGGED IN OR UNPLUGGED HOWEVER COMMUNICATOR WAS STILL UNRESPONSIVE. CONSUMER ALSO SAID THAT COMMUNICATOR HASN'T BEEN DROPPED OR GOTTEN WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758859 ↗
• InjuryNov 4, 2024Premature Discharge of Battery; High impedance; Battery Problem; Premature Discharge of Battery; High impedance; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE IMPEDANCE ISSUE WAS KNOWN ON CONTACT 7. AFTER RUNNING IMPEDANCE MEASUREMENTS ALL CONTACTS ON THE RIGHT LEAD WERE OUT OF RANGE. THE DEVICE WAS AT EOS WITH 1% BATTERY (WHICH ACCORDING TO THE HCP WAS PREMATURE AS THE FINAL SESSION REPORT SAID IT HAD 6 MONTHS BEFOREERI). AFTER CONNECTING TO A NEW NEUROSTIMULATOR ALL IMPEDANCES EXCEPT CONTACT 7 WERE NORMAL. THE REP HAD THE HCP DO SOME POCKET MANEUVERS WHILE THEY RAN IMPEDANCE MEASUREMENTS AND EVERYTHING WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600158 ↗
• MalfunctionNov 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MDT REP REPORTED THAT SINCE IMPLANT OF PERCEPT PC, THE ADAPTOR WAS NOT LISTED IN THE COMPONENTS FEATURE. IT IS UNCLEAR IF THIS WAS RELATED TO THE TRANSFER OF SETTINGS FROM THE ACTIVA PC TO THE PERCEPT PC. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599826 ↗

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-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-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-0184-2009 · Jun 14, 2008 · Terminated
  Medtronic DBS" 3387S-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
• 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.