ACTIVA RC 37612 (UDI 00643169529762)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,839 adverse event reports that list this exact device (DI 00643169529762), received between Nov 8, 2016 and Sep 22, 2026 — classified as 431 injuries, 2,408 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (920 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 2,839 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860428 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem; Failure to Power Up

  It was reported that reason for call was to report that the recharger won't turn on and the battery lights are scrolling up and down since yesterday. Caller said that patient recharges once a week and in between recharge sessions keeps the recharger in the case. Reviewed recommendation to keep recharger in plugged in dock in between recharge sessions. Reviewed troubleshooting steps twice however issue was not resolved. Replacement request was sent to repair to replace the recharger. Caller did say that patient needs to recharge. Caller was directed to contact managing physician's office to check if they can go there to recharge patient's implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851339 ↗
• InjurySep 21, 2026Delayed Charge Time; Insufficient Device Problem Information

  It was reported that patient states recharging is taking longer and she occasionally feels a baby is kicking around her abdominal implant. Manufacturer representative (rep) did an impedance check, impedance check showed within range.  Patient received a letter that her battery might be outdated. A battery replacement was scheduled. Rep reports issue was resolved. Additional information was received from manufacturer representative (rep). Rep reported the cause of the recharging taking longer was unknown. Rep reports the implantable neurostimulator (INS) was replaced and the issue was resolved. Rep clarified the feeling of a baby kicking was referring to the patient thinking there was a device issue. Information was confirmed by a physician.

  Patient problems: Insufficient Information

  MAUDE report 50841705 ↗
• MalfunctionSep 7, 2026Connection Problem; Material Integrity Problem

  Caller called back stating that they had received the replacement DTC, but it still won't charge the INSR. Agent requested to transition the INSR to WR through repair. Patient rep called back to request tracking number for the repair order. Reviewed shipping considerations with the caller and reviewed that the tracking number should be available tomorrow. Caller said the devices needed to be received tomorrow because the patient needed to charge and said they would call back to get the tracking number tomorrow. Contact called back and noted they had received WR but needed manual. Agent provided via email. Caller states the pt doesn't have a pt programmer to her knowledge (caller was not with the pt at time of the call) but will check with pt's parents. Agent reviewed options in the instance the pt programmer was lost or if the pt never received a pt programmer. Agent reviewed key differences between WR and INSR. Caller will call back if further assistance needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50648111 ↗
• MalfunctionSep 2, 2026Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570897 ↗
• MalfunctionAug 7, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170114 ↗
• MalfunctionJul 29, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069935 ↗
• MalfunctionJul 14, 2026Battery Problem

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 25814102 ↗
• MalfunctionJun 16, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THEY HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515928 ↗
• MalfunctionJun 15, 2026Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A CLINIC INTERACTION INVOLVING A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG), THERE WAS AN INABILITY TO CONNECT TO THE DEVICE AND THE RECHARGER BEEPED AND TURNED RED WHEN ATTEMPTING TO RECHARGE. THE AGENT WALKED THE MDT REP THROUGH INITIATING A PHYSICIAN RECHARGE MODE, AND THE REP PLANNED TO CALL BACK IF NEEDED ONCE THAT WAS COMPLETE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512471 ↗
• MalfunctionJun 12, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS THE PATIENT REPORTED THAT MAYBE A WEEK AGO OR SO AGO, THEY NOTICED THE CONNECTOR PIN ON THE DESKTOP CHARGER WAS BROKEN AND THAT WHEN THEY PLUGGED IT INTO THE RECHARGER LAST NIGHT ((B)(6) 2026), THE PORT ON THE RECHARGER CRACKED AND WOULDN'T HOLD THE CORD IN PLACE TO CHARGE THE RECHARGER ANYMORE. THE PATIENT STATED THEY LOOKED AT IT UNDER A MICROSCOPE AND THE PINS WERE BROKEN. PATIENT SERVICES REVIEWED WITH THE PATIENT THAT THE 37751 WAS NO LONGER BEING MANUFACTURED AND THAT THEY WOULD HAVE TO TRANSITION TO THE WIRELESS RECHARGING SYSTEM AND ADVISED THE PATIENT THEY WOULD REACH OUT TO THE FIELD ABOUT THE ISSUE TO START THE REPLACEMENT PROCESS. PATIENT SERVICES REVIEWED THAT A REPRESENTATIVE WOULD HAVE DELIVER THE WIRELESS SYSTEM TO THE PATIENT AND SHOW THEM HOW TO USE IT. AN EMAIL WAS SENT TO THE FIELD TO NOTIFY THEM OF THE SITUATION. PATIENT STATED THEIR IMPLANTED NEUROSTIMULATOR BATTERY WAS EXPECTED TO LAST MAYBE 3-4 DAYS. PATIENT SERVICES CALLED FIRST REP AND LEFT A MESSAGE AND WAS ABLE TO CALL THE OTHER REP AND CONTACTED THEM. THEY AGREED TO RECEIVE THE SHIPMENT. PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482492 ↗
• MalfunctionJun 12, 2026Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT STATED THE RECHARGER ISN'T WORKING. PATIENT SAID THE BLACK BOXES ON THE BOTTOM COME UP BUT THEY DON'T STAY UP. AGENT ASKED, PATIENT SAID THE ISSUE STARTED LAST WEEK. PATIENT MENTIONED THEY CHARGE WEEKLY AND CHARGE OVERNIGHT. PATIENT CONFIRMED THERE WAS NO DAMAGE TO THE DESKTOP CHARGER. AGENT HAD PATIENT START A CHARGING SESSION OF THE IMPLANT AND PATIENT REPORTED 8 COUPLING BOXES FILLED IN. AGENT REVIEWED GOOD COUPLING. PATIENT THEN SAID IF THEY WAIT A MINUTE THE BOXES WILL GO ALL OUT TO 0 AND THEN ON THE NEXT CYCLE A CLICKING SOUND HAPPENS AND EVERY 45 SECONDS THEY ARE MOVING THE ANTENNA OVER THE IMPLANT. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGING ANTENNA.". PATIENT CALLED BACK AND SAID THEY RECEIVED THE REPLACEMENT ANTENNA AND HAD A SUCCESSFUL CHARGING SESSION WITH THE REPLACEMENT ANTENNA WHERE THEY CHARGED THEIR INS UP TO 100% CHARGE HOWEVER TODAY IT WASN'T WORKING WHEN THEY TRIED TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR(INS). PATIENT DESCRIBED GETTING THE 'REPOSITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481825 ↗
• MalfunctionJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING TROUBLE CHARGING THE IMPLANTED NEUROSTIMULATOR. CALLER SAID THE INSR IS DEAD AND THEY HAVE TRIED PLUGGING IT INTO DIFFERENT OUTLETS. CALLER ALSO SAID THE CORD IS FRAYED AT THE TOP WHERE IT GOES INTO THE CHARGER. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT. PATIENT WAS ALSO ON THE PHONE. IT WAS REVIEWED THAT IS THE DTC DOESN'T RESOLVE THE ISSUE THEY WILL NEED TO TRANSITION TO THE WR. THE RECHARGER IS NOT WORKING, IT IS NOT SHOWING THAT IT CHARGES, IT'S NOT BLINKING. THE DTC WAS RECENTLY REPLACED, THE PATIENT CHARGES EVERY OTHER DAY AND IT WORKED UP UNTIL YESTERDAY. WORKED WITH CALLERS TO START CHARGING THE PATIENT'S IMPLANT BUT THE SCREEN SHOWED AN EMPTY INSR BATTERY SCREEN AND DID NOT CHANGE DESPITE CHECKING CONNECTIONS/UNPLUGGING/ REPLUGGING. CALLER SAID PATIENT CHARGES EVERY OTHER DAY AND SHOULD HAVE CHARGED YESTERDAY BUT COULD NOT BECAUSE IT WAS NOT WORKING. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. REVIEWED THE WIRELESS TRANSITION PROCESS AND THE REP WILL BE NOTIFIED TO START THE TRANSITION TO THE WIRELESS SYSTEM PROCESS. OFFERED AND SENT EMAIL TO THE REPS IN THE AREA, REDIRECTED TO THE PATIENT'S DOCTOR. ADDITIONAL INFORMATIO

  Patient problems: Convulsion/Seizure; Shaking/Tremors

  MAUDE report 25452962 ↗
• MalfunctionJun 9, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS CALLER STATED THAT THE RECHARGER IS NOT WORKING AND THEY THINK THE CHARGER IS BROKEN. CALLER REPORTED THE RECHARGER CORD IS BROKEN AS WELL. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DEVICE. CALLER ALSO REQUESTED A DRAPE. CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL. CALLER SAID THAT THE FACILITY THAT PATIENT LIVES IN CALLED INTO PATS AND WAS SENT THE WIRELESS RECHARGER/DRAPE. CALLER SAID FACILITY DOESN'T KNOW HOW TO USE EQUIPMENT. CALLER WASN'T WITH NEW EQUIPMENT BUT AGENT EDUCATED CALLER ON HOW WIRELESS RECHARGER SYSTEM WORKS. CALLER SAID THEY WOULD HAVE THE STAFF AT THE PATIENT'S FACILITY CALL FOR EDUCATION. FACILITY MAY WANT MEDTRONIC REPRESENTATIVE TO COME OUT AND EDUCATE. CALLER SAID THAT THE PATIENT'S DESK TOP CHARGER CONNECTOR PIN WAS BROKEN AND REQUESTED REPLACEMENT. AGENT EMAILED REPAIR TO SEND REPLACEMENT DESK TOP CHARGER. CALLER SAID THEY WOULD USE THE LEGACY RECHARGER AND NEW DESK TOP CHARGER UNTIL THE STAFF WAS COMFORTABLE WITH HOW TO USE NEW WIRELESS RECHARGER EQUIPMENT. CALLER SAID THAT THE FACILITY HAD BROKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25440408 ↗
• InjuryJun 8, 2026Failure to Deliver Energy; Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN THE HOSPITAL. THE PATIENT REPRESENTATIVE SAID THE INS WAS UNABLE TO CHARGE, THE BATTERY LEVEL COULD NOT BE READ OR CHECKED, AND THE PROGRAMMER ALSO APPEARED TO NOT WORK. THERE WAS CONCERN THE THERAPY WAS NOT WORKING AND MAY HAVE BEEN TURNED OFF BECAUSE THE PATIENT WOKE UP WITH A RETURN OF BASELINE PARKINSON¿S SYMPTOMS AND UNABLE TO MOVE AT ALL. PATIENT REP DESCRIBED IT AS IF THERE WAS NO DEEP BRAIN STIMULATION AND NO MEDICATION. PHONE-BASED TROUBLESHOOTING SUPPORT FOR THE EXTERNAL EQUIPMENT WAS OFFERED BUT DECLINED IN FAVOR OF IN-PERSON TROUBLESHOOTING SUPPORT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURING REP. IT WAS DETERMINED THAT DBS WAS OFF DUE TO NORMAL BATTERY DEPLETION. LEGACY PROGRAMMER HAD DEPLETED AAA BATTERIES. BATTERIES REPLACED AND DBS WAS ABLE TO BE PROGRAMMED ON. IMPEDANCES NORMAL. ISSUE RESOLVED. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURING REPRESENTATIVE AFFIRMING THAT HOSPITALIZATION WAS DUE TO DBS THERAPY BEING OFF AFTER DEPLETING TO 0% DUE TO NORMAL BATTERY DEPLETION WITH ONSET SYMPTOM MAY 13TH. REP WAS ABLE TO RECHARGE IMPLANT TO 50% AND TURN ON THE

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25428012 ↗
• MalfunctionMay 21, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED PATIENT HAD TO DO AN MRI OF THE BRAIN. THE REP CAME IN AND TURNED THE DBS OFF AND ON SO THEY COULD DO THE MRI. PATIENT ALSO MENTIONED WHEN THE STIMULATOR GETS SHUT OFF, IT IS LIKE SOMEONE IS STICKING YOU WITH A CATTLE PROD AND THEIR FINGERS AND TEETH HURT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock; Pain

  MAUDE report 25241742 ↗
• MalfunctionMay 21, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONNECTOR PIN WAS LOOSE ON THE DESKTOP CHARGER. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241238 ↗
• MalfunctionMay 7, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT MENTIONED UNRELATED MEDICAL HISTORY. THIS INCLUDED PATIENT SAID THEY STARTED GETTING SHOCKED WHEN THEY WERE ALMOST DONE CHARGING. THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE CAUSE OF THE SHOCKING SENSATION NEAR THE END OF CHARGING WAS DETERMINED TO BE RELATED TO THE RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) HAVING FULLY DEPLETED, WITH THE SENSATION OCCURRING WHEN STIMULATION WAS RESTARTED AFTER RECHARGING. THE SENSATION WAS BELIEVED TO ORIGINATE FROM THE INS WHEN THERAPY WAS TURNED BACK ON. RESOLUTION STEPS INCLUDED REPEATING RECHARGING EDUCATION TO HELP THE PATIENT AVOID FULL DEPLETION IN THE FUTURE. THE ISSUE HAS BEEN RESOLVED, THE EXACT ONSET DATE IS UNKNOWN. THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.

  Patient problems: Electric Shock

  MAUDE report 25115800 ↗
• MalfunctionMay 6, 2026Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THE CONNECTOR PIN WAS BENT FROM ACCIDENTALLY PLUGGED THE DESKTOP CHARGER INTO THE INSR UPSIDE DOWN BY ACCIDENT. THE PATIENT ALSO REPORTED IT WAS TAKING THEM LONGER TO CHARGE. THE INSR (INS RECHARGER) CHARGE LEVEL WAS ONLY SHOWING 1/2 FULL DESPITE BEING PLUGGED IN ALL THE TIME. THE ISSUE WAS WITH THE INSR CHARGING FROM THE A/C POWER SOURCE, NOT CHARGING THE INS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090125 ↗
• MalfunctionMay 4, 2026Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT REP WAS TOLD BY PATIENT THAT HE HASN'T USED DBS THERAPY FOR OVER 10 YEARS. REP THINKS THE IMPLANT IS IN OVERDISCHARGE. TECHNICAL SERVICES(TS) REVIEWED KEY SEQUENCES TO PUSH TO GET WIRELESS RECHARGER TO DO A PHYSICIAN RECHARGE MODE(PRM). SEE 607759025 FOR PH DEVICE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072586 ↗
• MalfunctionMay 1, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE METAL CONNECTOR HEAD OF THE RECHARGER ADAPTER WAS BENT OR KINKED. THE ADAPTER WAS REPLACED. THE ISSUE WAS REPORTED AS RESOLVED, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059173 ↗
• MalfunctionMay 1, 2026Low impedance

  IT WAS REPORTED THAT HCP ASKING IF PATIENT CAN GET MRI NEEDED BUT SHE STATES HE HAS IMPEDANCE ISSUES: ELECTRODE IMPEDANCES: LOW ON BIPOLAR 0X1 FOR L STN THERAPY IMPEDANCES: 540 OHMS L STN AT 3.9MA (ON NEW SETTINGS AVOIDING CONTACTS 0 AND 1) AND 850 OHMS AT CURRENT 6.7MA ON R STN. NO KNOWN CAUSE. HCP WAS ADVISED TO NOT DO MRI PER FDA GUIDANCE. CONTACTS ARE NOT USED FOR PROGRAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056776 ↗
• MalfunctionApr 30, 2026Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT STATED THEY HAD REPEATEDLY INFORMED THE HEALTHCARE PROVIDER THAT THE THERAPY SETTINGS CAUSED TINGLING SENSATIONS IN THE LIPS, TONGUE, AND FACE, AND THAT THESE CONCERNS HAD BEEN ONGOING FOR MORE THAN SEVERAL MONTHS, BUT NO ONE HAD EVER CALLED THEM TO SCHEDULE AN APPOINTMENT. THE PATIENT REPORTED THEY HAD NOT BEEN USING THE THERAPY AND STATED IT HAD BEEN SEVERAL MONTHS SINCE THE DEVICE WAS LAST RECHARGED. WHEN ATTEMPTING TO RECHARGE, A "REPOSITIONING ANTENNA" MESSAGE WAS DISPLAYED. THE PATIENT ALSO REPORTED RECEIVING A POOR COMMUNICATION MESSAGE WHEN ATTEMPTING TO COMMUNICATE WITH THE IMPLANTED NEUROSTIMULATOR USING THE PATIENT PROGRAMMER. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Paresthesia

  MAUDE report 25039185 ↗
• MalfunctionApr 27, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT HAVING PROBLEMS WITH THE RECHARGER, SAID THAT THE PADDLE STARTED ACTING UP AND NOT RESPONSIVE. CALLER SAID THAT THEY CALLED THE LOCAL REPRESENTATIVE, THE ORANGE LIGHT CAME ON AND THEY DID A HARD RESET. CALLER SAID THAT THE REPRESENTATIVE DID REPLACE THE CORDS FOR THE RECHARGER AND THEY HAVE BEEN ABLE TO RECHARGE THE IMPLANT. CALLER SAID THAT THEY LIKE TO KEEP THE IMPLANTED BATTERY CHARGED AT 75%. WHEN ASKED, CALLER SAID THAT THE RECHARGER IS IN THE DOCK WHICH IS PLUGGED IN. CALLER SAID THAT THE STAFF IS FAMILIAR WITH THE USE AND CARE OF EXTERNAL EQUIPMENT. CALLER ALSO SAID THAT PATIENT SAW THE NURSE PRACTITIONER YESTERDAY AND EVERYTHING SEEMED TO BE WORKING AS EXPECTED REGRADING THE IMPLANT. WHEN ASKED, CALLER SAID THAT RECHARGING WAS NOT EVEN ATTEMPTED DURING THE APPOINTMENT. CALLER DID SAY THAT AT THE APPOINTMENT INDICATED THAT INTERNAL BATTERY IS CHARGED TO 75%. THEN CALLER SAID THAT MORE RECENTLY THEY NOTICED THAT THE BATTERY LIGHTS ARE RAPIDLY MOVING. RECHARGER NOT CHARGING. CALLER ISN'T WITH THE PATIENT RIGHT NOW. WHEN ASKED, CALLER SAID THAT THEY DO USE THE PATIENT PROGRAMMER TO CONNECT AND RIGHT NOW ON THE MIDDLE ROW IS SEEING TWO ADDITIONAL ICONS, SAID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998809 ↗
• MalfunctionApr 27, 2026Overheating of Device; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DTC IS GETTING HOT AND THE CONNECTOR PIN IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994162 ↗

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-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.