Activa® PC 37601 (UDI 00763000175719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 410 adverse event reports that list this exact device (DI 00763000175719), received between Mar 18, 2019 and Sep 17, 2026 — classified as 3 deaths, 199 injuries, 208 malfunctions.

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

20 other recalls cover devices cleared under the same FDA submission (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 410 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50810807 ↗
• InjuryAug 18, 2026Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  It was reported that patient got an infection of the lead Oct 2024, and healthcare provider (HCP) waited until it cleared before implanting in Dec. 2024. Caller reported that symptoms were bad since patient was without therapy. Agent redirected caller back to HCP and gave a few listing of HCP for caller to inquire about finding a different doctor to reprogram patient.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50308165 ↗
• InjuryJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PREVIOUS INS BATTERY WAS REPLACED BECAUSE THE "BATTERY WAS BAD.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587363 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CALLER INITIALLY STATED THAT THE PATIENT HAD 4 LEADS BUT HAD TO HAVE 2 OF THEM REMOVED ON (B)(6) 2026 DUE TO AN ABSCESS. CALLER WANTED TO KNOW IF PATIENT IS STILL MRI CONDITIONAL OR IF THIS AFFECTS MRI ELIGIBILITY. AGENT REVIEWED PATIENT'S IMPLANT RECORDS AND THAT SHOWED MANUFACTURER SYSTEM (WITH 2 LEADS) WAS IMPLANTED IN 2019. HOWEVER, CALLER STATED THAT PATIENT HAD NON-MANUFACTURER LEADS IMPLANTED ON (B)(6) 2021 BUT THE NOTES DIDN'T INDICATE IF THE MANUFACTURER COMPONENTS HAD BEEN EXPLANTED. CALLER WAS GOING TO LOOK FURTHER INTO WHAT THE PATIENT CURRENTLY HAS IMPLANTED. AGENT REVIEWED THAT IF, BY CHANCE, PATIENT HAS A MIXED SYSTEM, WE WOULD NOT RECOMMEND MRIS. SINCE THE STATUS OF THE MANUFACTURER IMPLANTABLE NEUROSTIMULATOR, EXTENSIONS AND LEADS ARE UNKNOWN, IT IS UNKNOWN IF THE ABSCESS ON MAY 5, 2026 IS RELATED TO THE MANUFACTURER OR NON-MANUFACTURER DEVICES.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427355 ↗
• MalfunctionMay 29, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT NOTIFIED A MANUFACTURER REPRESENTATIVE (REP) THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED AROUND SINCE IMPLANTATION AND IT HITS THEIR RIBS. FOLLOW UP WAS COMPLETED TO OBTAIN ADDITIONAL INFORMATION AND THE REP INDICATED THAT CAUSE WAS NOT DETERMINED, NO ACTIONS WERE TAKEN TO ADDRESS THIS, AND ISSUE REMAINS UNRESOLVED. THIS INFORMATION WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333219 ↗
• InjuryMay 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY AN ALLIED HEALTHCARE PROVIDER AND PATIENT REPRESENTATIVE THAT THE PATIENT WAS CURRENTLY HOSPITALIZED DUE TO AN ABRUPT RETURN OF UNCONTROLLABLE DYSKINESIA FOR THE PAST SEVERAL DAYS. IT WAS REPORTED THAT SIMILAR SYMPTOMS HAD OCCURRED IN THE PAST WHEN DEEP BRAIN STIMULATION WAS TURNED OFF AND RECALIBRATED, AND THAT THE DEVICE HAD NOT BEEN CHECKED SINCE 2020. THE PATIENT WAS UNABLE TO EAT, HOLD A DRINK, AND SLID OFF A COUCH BECAUSE OF THE DYSKINESIA. THE PATIENT REP DESCRIBED THE PATIENT AS FLOPPING ALL OVER WITHOUT CEASING. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED AND NOTHING WAS REPORTED TO BE OBSERVED IN RESPECT TO THE DEEP BRAIN SYSTEM. INFECTION WAS RULED OUT. THE PATIENT REPRESENTATIVE WAS UNSURE IF THE IMPLANTABLE NEUROSTIMULATOR AND/OR PROGRAMMER WAS FUNCTIONAL. ADDITIONALLY, PATIENT REPRESENTATIVE REPORTED THAT PATIENT WAS EXPERIENCING HALLUCINATIONS AND MENTAL STATUS, BUT WERE UNSURE IF WAS RELATED TO THE DEEP BRAIN STIMULATION (DBS) THERAPY/DEVICE OR RELATED TO A KNOWN PROSTATE ISSUE THAT WAS DESCRIBED AS PRE-EXISTING. THE PATIENT REPRESENTATIVE REPORTED THAT PATIENT HAD A HISTORY OF BLADDER RETENTION WITH LAST EVENT TAKING PLACE ABOUT A YEAR EARLIER.

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Dyskinesia; Insufficient Information

  MAUDE report 25271554 ↗
• InjuryDec 15, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PATIENT'S (PT) PREVIOUS INS BATTERY WENT DEAD WHILE THEY WERE WATCHING TV, NOTING THAT THE "WHOLE ROOM LOOKED LIKE IT WAS DOING A FLIP-FLOP." THE PATIENT MENTIONED THAT THEY HAD BEEN HAVING SO MANY BACK PROBLEMS THAT THEY DIDN'T PAY ATTENTION TO THE INS BATTERY LEVEL. THE PATIENT SAID THEY WERE TAKEN TO HOSPITAL ON AN EMERGENCY BASIS TO HAVE THE INS BATTERY REPLACED. AGENT DOCUMENTED REPORTED EVENT.

  Patient problems: Dizziness; Insufficient Information

  MAUDE report 23810216 ↗
• InjuryNov 28, 2025Peeled/Delaminated; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Patient Device Interaction Problem; Peeled/Delaminated; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT EVERY ONCE IN A WHILE, WHEN THE PATIENT TURNS RIGHT, THEY GET A JOLT OF ELECTRICITY DOWN THEIR RIGHT ARM WHICH STARTED 7-10 DAYS AGO. PATIENT SAID THE JOLT STARTLES THEM AND THEIR ARM TWITCHES A LITTLE BIT BUT NOT FOR VERY LONG. PATIENT SAW THE HEALTHCARE PROVIDER ABOUT 10 DAYS AGO AND WAS TOLD THE BATTERY WAS DOWN TO 2%. PATIENT TURNED STIM OFF AND IT MADE A SIGNIFICANT DIFFERENCE. PATIENT WANTED TO KNOW HOW URGENT THIS ISSUE IS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock; Twitching

  MAUDE report 23673954 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CALLER NOTICED A RED AREA ON THE PATIENT¿S CHEST NEAR THE IMPLANTABLE NEUROSTIMULATOR (INS) WHILE GIVING THE PATIENT A BATH ON SATURDAY. THIS MORNING, A NURSE OBSERVED REDNESS AND PUFFINESS BEHIND THE PATIENT¿S EAR, AS WELL AS A RED AREA ON THE PATIENT¿S NECK NEAR THE LEADS. THE PATIENT¿S INS DISPLAYED AN END OF SERVICE (EOS) MESSAGE, AND PATIENT SERVICES REVIEWED THE MEANING OF THE MESSAGE. THE CALLER STATED THEY CONTACTED THE HEALTHCARE PROVIDER, WHO ADVISED TAKING THE PATIENT TO THE ER, AS THEY SUSPECT A POSSIBLE INFECTION.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 22958105 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE MEDIAL UPPER CORNER OF THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) BROKE THROUGH THE SKIN ON THE CHEST, RESULTING IN APPROXIMATELY 1.5 CM OF DEVICE EXPOSURE. SIGNIFICANT PATIENT WEIGHT LOSS OVER THE PAST TWO YEARS WAS IDENTIFIED AS A CONTRIBUTING FACTOR. SURGICAL INTERVENTION INCLUDED EXPLANTATION OF THE RIGHT INS AND PARTIAL EXPLANT OF THE EXTENSIONS, WHICH WERE CUT BELOW THE LEAD/EXTENSION CONNECTION TO PROTECT THE LEAD. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 22844277 ↗
• MalfunctionAug 7, 2025Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING SENSATION WHILE WEARING A FITBIT WHEN A PREVIOUS IMPLANTABLE NEUROSTIMULATOR WAS ACTIVE. THE PATIENT DISCUSSED THE ISSUE WITH THEIR HEALTHCARE PROVIDER AND WAS INFORMED THAT THE FITBIT SHOULD NOT HAVE CAUSED A SHOCKING SENSATION. THE PATIENT REPORTED THAT THE SENSATION CEASED AFTER DISCONTINUING USE OF THE FITBIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Electric Shock

  MAUDE report 22742577 ↗
• InjuryAug 5, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT MENTIONED REQUIRING A REPLACEMENT ON (B)(6) 2025, DUE TO FRAYED WIRING ON THEIR PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS), WHICH WAS CAUSING SEVERE SHAKING IN THEIR HANDS.

  Patient problems: Shaking/Tremors

  MAUDE report 22710853 ↗
• MalfunctionJul 16, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT DURING A ROUTINE BATTERY REPLACEMENT FOR A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG), LOW IMPEDANCES WERE OBSERVED BETWEEN BI-POLAR CONTACTS 0-2, INITIALLY MEASURED AT 36 OHMS AND THEN 55 OHMS UPON RETESTING. IMPEDANCES WERE REPORTED TO BE WITHIN NORMAL LIMITS PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527561 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SURGICAL COMPLICATIONS DURING THEIR IMPLANT PROCEDURE IN 2019, INCLUDING A BLEED, INTRACEREBRAL HEMORRHAGE, AND SUBDURAL HEMATOMA IN THE LEFT BRAIN, WHICH LED TO SEVERAL SEIZURES AND CEREBROVASCULAR ACCIDENTS (CVAS), REQUIRING INTUBATION, ICU CARE, AND MANY MONTHS OF RECOVERY. THE PATIENT UNDERWENT REHABILITATION FOLLOWING THESE EVENTS, WHICH RESULTED IN SIGNIFICANT LIMITATIONS. THE PATIENT WAS LATER HOSPITALIZED FOR GENERALIZED WEAKNESS AND CONFUSION, WITH A CT SCAN SHOWING ACUTE ENCEPHALOPATHY SURROUNDING THE LEFT LEAD. THE PATIENT ALSO REPORTED RIGHT LEG AND GROIN PAIN, ALONG WITH NUMBNESS IN BOTH FEET. SUBSEQUENTLY, THE PATIENT¿S DBS WAS PROGRAMMED, SIGNIFICANTLY CONTROLLING THEIR TREMORS, AND THE PATIENT DID WELL FOR THE NEXT FOUR YEARS UNTIL THE ROUTINE BATTERY REPLACEMENT IN 2024.

  Patient problems: Convulsion/Seizure; Encephalopathy; Hematoma; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 22500702 ↗
• MalfunctionMay 13, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) AND HEALTHCARE PROVIDER (HCP) WHO REPORTED THE FIRST TABLET USED TO INTERROGATE THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED ERROR MESSAGE ¿SYSTEM ERROR-THE SYSTEM HAS ENCOUNTERED AN UNSUSPECTED ERROR, RESTART, ERROR CODE 0X4B81F1A3.¿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

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

  MAUDE report 22012533 ↗
• InjuryApr 25, 2025High impedance; Migration or Expulsion of Device; Unintended Collision; High impedance; Migration or Expulsion of Device; Unintended Collision

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THE PROCEDURE TOOK PLACE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915148 ↗
• InjuryApr 18, 2025Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem; Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM PATIENT STATES IMPLANTED NEUROSTIMULATOR WAS REPLACED A WEEK AGO TODAY. ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER STATING THE INS WAS REPLACED AND SENT BACK TO MEDTRONIC. THEY CALLED MEDTRONIC TO FIX THE PROBLEM AND THEY HAD TROUBLING CHARGING THE INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862982 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH PUS OOZING FROM THE INCISION SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET. THE PATIENT SUGGESTED RECENT DENTAL WORK MIGHT HAVE INTRODUCED A PATHOGEN INTO THEIR BODY, POTENTIALLY SEEDED AT THE IPG POCKET SITE. DIAGNOSTICS INDICATED THAT IMPEDANCES WERE NORMAL, AND THE PATIENT RESPONDED WELL TO DBS THERAPY. THE SURGEON INSTRUCTED THE PATIENT TO REPORT TO THE HOSPITAL ER FOR EVALUATION OF THE INCISION SITE AND SUBSEQUENTLY DECIDED TO EXPLANT THE ENTIRE DBS SYSTEM DUE TO INFECTION. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT THROUGH SURGICAL INTERVENTION.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 21511660 ↗
• InjuryMar 3, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT AN IMPLANTABLE PULSE GENERATOR (IPG) FOR DEEP BRAIN STIMULATION HAD IMPEDANCE ISSUES. THE PATIENT WAS EXPERIENCING THESE ISSUES, AND A POSSIBLE SYSTEM EXPLANT AND REVISION WERE CONSIDERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION CONFIRMING A REVISION SURGERY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511530 ↗
• InjuryJan 31, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT BEGAN TO NOTICE A LITTLE BIT OF TREMBLE. THE PATIENT'S REPRESENTATIVE CHECKED THE IMPLANTABLE NEUROSTIMULATOR USING A PATIENT PROGRAMMER AND OBSERVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) SCREEN. THE REPRESENTATIVE WAS INFORMED ABOUT THE MEANING OF THE ERI AND INSTRUCTED ON HOW TO CHECK THE BATTERY VOLTAGE OF THE DEVICE. AT THE TIME OF THE CALL, THE REPRESENTATIVE WAS NOT WITH THE PATIENT, AND THE THERAPY STATUS COULD NOT BE DETERMINED. THEY WERE ADVISED TO CONTACT THE PATIENT'S HEALTHCARE PROVIDER FOR FURTHER ASSISTANCE. HOWEVER, THE PATIENT DID NOT HAVE A MANAGING HEALTHCARE PROVIDER AT THAT TIME, AND THE REPRESENTATIVE MENTIONED THAT THEIR INSURANCE WAS IN THE PROCESS OF FINDING A NEW PROVIDER. A LIST OF PHYSICIANS FAMILIAR WITH THE THERAPY WAS EMAILED TO THE REPRESENTATIVE. ADDITIONAL INFORMATION WAS RECEIVED BY THE PATIENT STATING THAT THEIR DBS WAS REPLACED IN ORDER TO RESOLVE THEIR MINOR TREMBLE AND THE ERI MESSAGE.

  Patient problems: Shaking/Tremors

  MAUDE report 21282975 ↗
• InjuryJan 21, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE BATTERY WAS INSTALLED IN 2019 AND WAS GOOD FOR FIVE YEARS. THE DEVICE WORKED WELL BUT WAS NOW GOING TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199981 ↗
• MalfunctionNov 15, 2024Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED, THAT THE DESKTOP CHARGER IS CONSTANTLY BREAKING. NO FACTORS REPORTED THAT LED TO THE ISSUE. INTERVENTIONS/ACTIONS TAKEN TO RESOLVE THE PROBLEM, INCLUDED REPLACING THE DEVICE. THE ISSUE WAS NOT YET RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED, FROM THE MANUFACTURER¿S REPRESENTATIVE (REP). WHICH WAS CONFIRMED, WITH THE HEALTHCARE PROVIDER (HCP). REPORTED, IT WAS THE METAL PIECE ON THE END OF THE CABLE THAT BROKE ON THE DESKTOP CHARGER. THE DEVICE WAS REPLACED. WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694182 ↗
• MalfunctionSep 18, 2024Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  PATIENT MENTIONED THEY RECEIVED A CERVICAL EPIDURAL STEROID INJECTION ON (B)(6), BUT DID NOT ELABORATE ON HOW THIS WAS RELATED. THEY ARE HOPING TO GET A BATTERY REPLACEMENT TO RESOLVE THEIR SYMPTOMS.

  Patient problems: Electric Shock; Insufficient Information; Numbness; Pain

  MAUDE report 20243502 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL BECAUSE OF A MAJOR SEIZURE. PATIENT SAID THEY ARE HAVING PAIN IN THE HEAD THAT THEY JUST NOTICED TODAY. THEY HAVE BEEN HAVING A LOT OF SEIZURES LATELY. THEY STARTED HAVING SEIZURES ONCE A MONTH, AND ABOUT 3 OR 4 WEEKS AGO, THEY STARTED HAVING THEM ONCE A DAY. THE PATIENT HAS A VAGUS NERVE STIMULATOR TOO AND SOMETIMES THEY CAN STOP THE SEIZURE WITH THE MAGNET BUT IT IS NOT A GUARANTEE. WHEN THEY USE THE PATIENT PROGRAMMER THEY GET ERI (ELECTIVE REPLACEMENT INDICATOR), AND THAT STARTED PROBABLY ABOUT A WEEK AGO. AGENT EXPLAINED THAT MEANS THEY NEED TO GET THEIR STIMULATOR REPLACED SOON. THE PATIENT CALLED BACK AND REPORTED THAT THEY WERE SEEING ERI EARLIER AND NOW THEY ARE SEEING EOS. AGENT REVIEWED EOS. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE DEVICE REACHED EOS DUE TO NORMAL DEPLETION. THE PATIENT WAS WORKING ON GETTING THE DEVICE REPLACED.

  Patient problems: Pain

  MAUDE report 20068408 ↗
• MalfunctionAug 21, 2024High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED OOR IMPEDANCES ( (B)(4) ) WERE NOTED ON CONTACT 11 IN PRE-OPERATIVE ON THE SYSTEM THAT WAS GOING TO BE REPLACED DUE TO REACHING ELECTIVE REPLAC EMENT INDICATOR (ERI). THE OOR IMPEDANCES ON CONTACT 11 REMAINED AFTER THE NEW GENERATOR WAS IMPLANTED ( (B)(4) ) EVEN AFTER IMPEDANCE CHECKS WERE PERFORMED AT MULTIPLE AMPLITUDES. IT WAS UNKNOWN WHICH LED TO THE ISSUE, BUT SINCE IMPEDANCES WERE ON AN UNUSED CONTACT AND CONSISTENT WITH WHAT WAS SEEN IN PRE-OP NO INTERVENTIONS WERE TAKEN. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE HIGH IMPEDANCE WASN¿T DETERMINED. THE PATIENT WAS ABLE TO ESTABLISH EFFECTIVE THERAPY USING THE OTHER CONTACTS. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY ATTENDED THE PATIENT¿S CARDIOVERSION PROCEDURE WHERE IMPEDANCES ON CONTACT 11 WERE STILL ELEVATED BEFORE THE PROCEDURE ( (B)(4) ). AFTER THE PROCEDURE THEY WERE ELEVATED AND OUT OF RANGE SHOWING HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.