Activa® RC 37612 (UDI 00763000384357)Recalls & reported problems

Summary

The FDA's MAUDE database contains 410 adverse event reports that list this exact device (DI 00763000384357), received between Jan 6, 2021 and Sep 28, 2026 — classified as 115 injuries, 295 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (100 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.

• MalfunctionSep 28, 2026Migration or Expulsion of Device; Patient Device Interaction Problem

  It was reported that the implantable neurostimulator (INS)  on the patient's left side seemed like it moved around a lot more than the INS in their right side. Patient stated that their cat jumped on their chest when they're sleeping and danced around with a lot of motion and patient thought this may have caused the INS to move more. Patient added that the INS gradually moved more and that the issue happened maybe 5 or several years ago. Patient mentioned that their INS was located on their left side about parallel with the line at the top of their breast, and that they also had another INS on the right side of their collar bone area. Agent redirected the patient to their HCP to further address the issue. When asked for HCP info.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914638 ↗
• MalfunctionSep 15, 2026Charging Problem; Communication or Transmission Problem

  It was reported that a patient with a deep brain stimulation implantable pulse generator (IPG) contacted support because the patient programmer was not connecting to the stimulator and the patient described breathing difficulty that was worst on the day of the call. The issue reportedly began several days earlier. The patient programmer displayed a warning that its batteries were low and needed to be changed, and after the patient replaced the batteries, the programmer connected to the stimulator and indicated the stimulator battery charge level was low. The patient also reported that therapy was off. The patient attempted to use a wireless recharger and handset to charge the stimulator, and the recharging application would not connect to the recharger, displaying ¿not found.¿ Multiple recharger resets were performed by holding the power button for 45 seconds, and repeated manual entry and scanning attempts of the recharger serial number were performed before the recharging application connected. Once connected, the recharging application displayed ¿my battery 0%,¿ ¿my therapy off,¿ and ¿excellent connection,¿ and charging was initiated. No symptoms were reported. 2026-Aug-04 RTG10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767747 ↗
• InjurySep 10, 2026Migration or Expulsion of Device; Malposition of Device; Battery Problem

  Patient problems: Shaking/Tremors

  MAUDE report 50723956 ↗
• MalfunctionAug 18, 2026Failure to Deliver Energy; Delayed Charge Time

  Patient problems: Shaking/Tremors

  MAUDE report 50293809 ↗
• InjuryAug 5, 2026Energy Output Problem; Electromagnetic Compatibility Problem

  It was reported that the patient (pt) had a cardioversion done, and had the device turned OFF. Post cardioversion, pt attempted to turn stimulation ON, as stimulation turned on, pt felt a strong surge, their entire body tense up, felt like an intense stimulation or shocking sensation. Caller reports they immediately turned stimulation back to OFF and wanted to have a manufacturing representative (rep) come check the device and turn therapy on. Caller reports post cardioversion their heart rhythm was sinus bradycardia, but after turning stimulation back to ON then OFF, their heart rhythm went back to irregular heart rhythms. They were redirected to NAS to page a rep.

  Patient problems: Arrhythmia; Device Overstimulation of Tissue; Electric Shock; Insufficient Information; Muscular Rigidity

  MAUDE report 50142488 ↗
• MalfunctionJun 17, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECHARGER IS NOT WORKING. CALLER SAID THE BATTERY LIGHTS ARE SCROLLING. CALLER TRIED PUSHING AND HOLDING THE POWER BUTTON FOR 40 SECONDS AND IT DIDN'T DO ANYTHING. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT. CALLER SAID THIS HAPPENED BEFORE AND THE WIRELESS RECHARGER (WR) WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528648 ↗
• InjuryJun 11, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PATIENT HAD A NEW BATTERY PUT IN (B)(6) OF LAST YEAR BECAUSE THEIR OLD ONE HAD BLOOD IN IT. *** SEE (B)(4) FOR EXTERNALS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473464 ↗
• MalfunctionJun 3, 2026Delayed Charge Time; Charging Problem

  IT WAS REPORTED THAT NORMALLY WHEN PT RECHARGES THEIR IMPLANTABLE NEUROSTIMULATOR (INS), THEY DON'T HAVE ANY ISSUES AND THEY HEAR THE FULLY CHARGED, TONAL SOUNDS WITHIN THE SAME AMOUNT OF TIME, SUCH AS: 30 MINUTES ON THE RIGHT AND 30 MINUTES ON THE LEFT AND THE LAST TIME THEY CHARGED WAS FRIDAY AND THE DBS THERAPY APP CONFIRMED THEIR INSS WERE BOTH 100 PERCENT BUT YESTERDAY WHEN THEY STARTED CHARGING THE RIGHT SIDE AND AFTER ABOUT 45 MINUTES THEY GOT THE TONES CONFIRMING THEY WERE FULLY CHARGED BUT WHEN THEY CHARGED THE LEFT SIDE, AFTER AN HOUR AND A HALF IT STILL DID NOT GIVE THE ASCENDING BEEP SO THEY STOPPED. CALLER ASKED IF THEY SHOULD BE ALERTED THAT THERE COULD BE SOMETHING WRONG WITH THE SYSTEM. REVIEWED SOME RECHARGING INFORMATION OF CHARGE SUFFICIENT/ CHARGE COMPLETE AND RECOMMENDED KEEPING AN EYE ON WHAT IS GOING ON. REVIEWED THE OPTION TO INFORM THE DOCTOR ABOUT VARIATIONS IN THE CHARGE DURATION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLED CALLER BACK 2 CALL RECORDINGS TO REVIEW THE ISSUE COULD BE CAUSED BY POSITIONING AND EXCELLENT CONNECTION VS GOOD CON NECTION CAN CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375735 ↗
• MalfunctionMay 29, 2026Failure to Deliver Energy; Energy Output Problem

  IT WAS REPORTED THAT PATIENT SYMPTOMS ARE JUST ABOUT BACK TO WHERE THEY WERE BEFORE THE BRAIN IMPLANT WAS PUT IN. THIS STARTED ABOUT 3-4 WEEKS AGO. THE CALLER INDICATES THAT THEIR SHAKING IS TERRIBLE WHEN THEY TRY TO CHARGE THE IMPLANTED NEUROSTIMULATOR. THEY TYPICALLY CHARGE ON SATURDAY MORNING. IT USED TO TAKE ABOUT AN HOUR TO AN HOUR AND 15 MINUTES TO CHARGE FOR THE WEEK, BUT NOW THEY ARE GETTING ABOUT 15 MINUTES WORTH OF A CHARGE AND THE RECHARGER SHUTS OFF. THE CALLER WAS ABLE TO CHARGE WHILE ON THE CALL WITH NO ISSUES. RECHARGER BATTERY WAS FULL ACCORDING TO THE LIGHTS. THEY SAID THE PATIENT NEVER USED THE HANDSET AND WOULD JUST CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS)  WITH THE RECHARGER WEEKLY, EVERY SATURDAY. PATIENT SERVICES HAD THE CALLER AND PATIENT BEGIN A CHARGING SESSION AND THEY SAW THE INS WAS 100% CHARGED, THEY HAD EXCELLENT CONNECTION AND THE THERAPY WAS OFF. REVIEWED THIS INFORMATION WITH THE CALLER AND PATIENT. CALLER SAID ASKED HOW THE THERAPY MIGHT BE OFF. PATIENT SERVICES EXPLAINED TO THE CALLER AND PATIENT THAT IF THE INS AT ONE POINT BEFORE THEIR NEXT CHARGING SESSION HAD DIED, THEY WOULDN'T HAVE KNOWN IF THEY WEREN'T USING THE HANDSET SO THE PATIENT H

  Patient problems: Pain; Shaking/Tremors

  MAUDE report 25337460 ↗
• MalfunctionMay 29, 2026Failure to Deliver Energy; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT REPORTED THEY BELIEVED THEIR STIMULATOR HAD QUIT WORKING. THEY FURTHER EXPLAINED AND STATED THAT THEY THOUGHT THIS BECAUSE THEY USUALLY CHARGED THEIR IMPLANT ON TUESDAY, THURSDAY AND SUNDAY AND A WEEK AGO SUNDAY ((B)(6) 2026) THEY WENT TO CHARGE THE IMPLANT AND THE IMPLANT BATTERY WAS AT 75% WHICH WAS THE USUAL LEVEL BUT IT ONLY TOOK ABOUT A MINUTE OR TWO TO CHARGE IT TO 100%. PATIENT STATED THEY THOUGHT MAYBE THAT WAS JUST A FLUKE SO THEY CHARGED IT AGAIN ON TUESDAY AND THURSDAY AND THE SAME THING HAPPENED AND WHEN THEY WENT TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) ON THIS PAST SUNDAY ((B)(6) 2026) IT WAS STILL AT 100% CHARGE AND THEY DIDN'T HAVE TO CHARGE IT. PATIENT SAID ANOTHER REASON THEY THOUGHT THE THERAPY WAS NO LONGER WORKING WAS BECAUSE THEY WERE JUST TALKING TO A FRIEND AND THE FRIEND SAID THAT SOMEONE BROUGHT TO THEIR ATTENTION THAT THE PATIENT'S HEAD WAS TILTED AND TURNED TO THE SIDE (WHICH THEY SAID OCCURRED ON THE SECOND THURSDAY OF MAY (PATIENT CONFIRMED THAT THEIR ISSUE STARTED IN (B)(6) 2026 ,) SO THE PATIENT THOUGHT IT WAS THE STIMULATOR THAT WAS AT FAULT. PATIENT SERVICES ASKED THE PATIENT IF THEY KNEW THEIR THERAPY WAS ON AND

  Patient problems: Insufficient Information

  MAUDE report 25332221 ↗
• MalfunctionMay 27, 2026Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED BY A MANUFACTURING REP REQUESTING INFORMATION ABOUT USING A WIRELESS RECHARGER TO PULL AN IMPLANTABLE NEUROSTIMULATOR (INS) OUT OF OVERDISCHARGE. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THEY WERE INFORMED BY PATIENT ON (B)(6) 2026 OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302467 ↗
• MalfunctionMay 26, 2026Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING A CHARGE-FREQUENCY CONCERN FOR APPROXIMATELY 6 MONTHS, NOTING THAT THE IMPLANTED NEUROSTIMULATOR BATTERY WAS DEPLETING FASTER THAN EXPECTED. THE PATIENT REPORTED CHARGING THE IMPLANT SEVERAL DAYS EARLIER AND LATER OBSERVED A BATTERY LEVEL OF APPROXIMATELY 50%, RATHER THAN THE PREVIOUSLY EXPECTED 75%. THE PATIENT STATED THAT THE MOST RECENT CHARGING SESSION WAS STOPPED EARLY DUE TO THE SESSION DURATION AND A CHANGE IN THE INDICATOR. THE PATIENT REPORTED NO RECENT PROGRAMMING CHANGES, THOUGH ADJUSTMENTS HAD BEEN MADE IN THE PAST, AND STATED THAT CHARGING SESSIONS HAD BEEN TAKING LONGER. CHARGING EXPECTATIONS AND FACTORS THAT MAY AFFECT BATTERY PERFORMANCE, INCLUDING DEVICE AGE, WERE REVIEWED. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER FOR FURTHER EVALUATION AND WAS ADVISED TO FULLY CHARGE THE IMPLANTED NEUROSTIMULATOR AND MONITOR BATTERY DEPLETION GOING FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283929 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH PARKINSON¿S DISEASE WHO WAS BEING TREATED WITH DEEP BRAIN STIMULATION THERAPY HAD AN IMPLANTED IMPLANTABLE NEUROSTIMULATOR AND EXPERIENCED AN INFECTION BENEATH THE POCKET. THE STIMULATOR WAS EXPLANTED (PARTIAL EXPLANT). THE EVENT WAS REPORTED AS RESOLVED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 25104689 ↗
• MalfunctionMay 1, 2026Delayed Charge Time

  IT WAS REPORTED THAT CHARGING THE BATTERY (NEW AROUND 2019) HAS ALWAYS TAKEN A LONG TIME. AT LEAST AN HOUR, USUALLY MORE. PATIENT (PT) CHARGES IT 2X A WEEK. THEY ARE UNSURE IF THIS IS NORMAL? PT REP TRIED CONTACTING SOMEONE ABOUT THIS. THEY WERE NO HELP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058210 ↗
• MalfunctionApr 20, 2026Intermittent Continuity; Display or Visual Feedback Problem; Electromagnetic Interference; Failure to Deliver Energy; Battery Problem

  IT WAS REPORTED THAT THE MANUFACTURING REP SAW THE PATIENT THIS AFTERNOON IN THE NEUROLOGIST'S OFFICE AND THE PATIENT DETERMINED THAT THE DEVICE HAD TURNED OFF. WHEN THE CALLER INTERROGATED THE DEVICE TODAY THEY WERE ONLY ABLE TO ACCESS RECHARGE DATA BACK TO (B)(6). THE PATIENT THOUGHT THE DEVICE TURNED OFF ON (B)(6) AND THEY WERE WONDERING IF IT TURNED OFF ON ITS OWN. THE CALLER DID NOT HAVE THE DATES FOR OTHER INSTANCES WHEN THEY THOUGHT THAT THERAPY HAD TURNED OFF. THEY SAID THEY THOUGHT IT TURNED OFF WHEN THEY WENT INTO DIFFERENT STORES. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925566 ↗
• MalfunctionApr 16, 2026Migration or Expulsion of Device; Overheating of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT SAID THEY WERE USING IT ONE DAY AND THEY FELT LIKE IT WAS "BURNING MY CHEST". THE PATIENT INDICATED THEY HAD LOST WEIGHT AND THEIR "BOOB" WAS NOW SMALLER AND THE INS WOULD SLIDE ALL AROUND SO THEY WOULD HAVE TO "CHASE IT ALL AROUND" WHEN THEY WENT TO CHARGE." THE PATIENT SAID THE BATTERY HAD MOVED UP TO THEIR NECK AREA. THEY SAID THAT THE INS HAD NEVER FULLY TAKEN AWAY THEIR FAMILIAR TREMOR WHICH THEY CALLED THEIR "HEAD TWITCH" BUT THE PAIN THEY USED TO HAVE IN THEIR NECK ALONG WITH IT WENT AWAY WHEN THEY GOT THE INS AT LEAST. PATIENT SAID THAT THEY GOT COMFORTABLE WITH THEIR DBS AND COULD ADJUST THEIR DBS TO WHERE THEIR HEAD TWITCH DOESN'T BOTHER IT IF THEY DON'T FOCUS ON IT, PATIENT SAID WHEN THEY FOCUS ON THEIR HEAD TWITCH IT GETS WORSE. PT ALSO MENTIONED THAT THEY HAD THEIR MUSCLES "TIGHTENED" SO THEIR HEAD ALWAYS TURNS TO THE LEFT. PT SAID THEY HAD ALWAYS BEEN ABLE TO FOLLOW THE WIRE (LEAD) ON THR RIGHT SIDE OF THEIR HEAD.

  Patient problems: Burning Sensation; Muscular Rigidity; No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 24905065 ↗
• MalfunctionMar 25, 2026Device Difficult to Program or Calibrate; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REASON FOR CALL WAS TO GET MRI AND REGISTRATION INFORMATION. THE CALLER STATED THAT THE X-RAYS SHOWED THAT THE PATIENT HAD TWO LEADS BUT THE REGISTRATION INFORMATION SHOWED ONLY ONE CURRENT LEAD. THE CALLER STATED THAT THE PATIENT HAS BEEN HAVING ISSUES WITH THE IMPLANTED SYSTEM. THE PATIENT MET WITH THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2026 AND THEY COULD NOT MAKE THE DESIRED THERAPY ADJUSTMENT. THE CALLER DID NOT HAVE ANY OTHER DETAILS ABOUT THE ISSUE THAT THE PATIENT WAS HAVING. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES REVIEWED MRI INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691678 ↗
• MalfunctionMar 23, 2026Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTED NEUROSTIMULATOR (INS) ON THE RIGHT SIDE IS NOT CHARGING, WHILE THE LEFT SIDE CHARGES NORMALLY. THE CALLER NOTED THAT THE RIGHT-SIDE INS WILL NOT CHARGE PAST 25%, AND THE RECHARGER CONNECTS BUT THEN STARTS BEEPING. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL AND MENTIONED THE ISSUE WAS DISCOVERED LAST WEEK AT THE NEUROLOGIST'S OFFICE, WHERE ONE SIDE SHOWED 100% CHARGE, AND THE OTHER WAS AT 20% AND OFF. THE CALLER STATED THE PATIENT IS IN A NURSING HOME, AND THE HEALTHCARE PROVIDER INDICATED THEY WOULD ARRANGE FOR A MANUFACTURER REPRESENTATIVE TO VISIT THE PATIENT THERE. THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTHCARE PROVIDER FOR FURTHER ASSISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667617 ↗
• MalfunctionMar 20, 2026Delayed Charge Time; Battery Problem; Charging Problem

  IT WAS REPORTED THAT IT HAS BEEN TAKING 3.5-4 HOURS TO CHARGE THE IMPLANTED DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) FROM 50% TO 100% OVER THE PAST 4-6 MONTHS. THE HEALTHCARE PROVIDER CHECKED THE BATTERY LEVEL OF THE IMPLANTED NEUROSTIMULATOR AND FOUND IT TO BE AT 100%. THE HEALTHCARE PROVIDER INDICATED THAT THE RECHARGER PROBABLY NEEDED TO BE REPLACED. THE CALLER WAS ASSISTED IN PAIRING THE HANDSET AND WIRELESS CHARGER, AND WAS ABLE TO CONNECT TO THE IMPLANT AND CHARGE WITH EXCELLENT CONNECTION. THE FUNCTION OF THE HANDSET/APPLICATION WAS EXPLAINED, AND THE CALLER WAS ADVISED TO CONTINUE CHARGING ON THEIR NORMAL SCHEDULE AND USE THE APPLICATION TO MONITOR CONNECTION QUALITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THEY SAW A RECALL WITH FA1183 TO WR200, WHICH THE PATIENT HAVE, AND IS REQUESTING FOR A REPLACEMENT. AGENT REVIEWED THE FIELD ACTION, AND REVIEWED TO THE PATIENT THAT THE FIELD ACTION IS FOR SPECIFIC SCENARIO WITH UNRESPONSIVE WIRELESS RECHARGER AFTER IT BECAME DEPLETED. THE PATIENT'S WIRELESS RECHARGER IS WORKING AS INTENDED, AND IS CHARGING THE INS UP TO 100% AND THAT THEY HAD TO RECHARGER THE INS MORE FREQUENT THAN THEY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647248 ↗
• MalfunctionMar 20, 2026Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT THEIR RECHARGER DOESN'T WORK, BECAUSE IT HASN'T BEEN USED FOR A LONG PERIOD OF TIME AS THEY WERE IN THE HOSPITAL. PATIENT STATED THAT THEY NOTIFIED THE REP LAST MONDAY, AND THEY WERE TOLD THAT THEY NEED A REPLACEMENT RECHARGER AND DOCK. AGENT HAD THE PATIENT PLUG IN THE DOCK, AND PLACE THE RECHARGER ON IT. PATIENT CONFIRMED THAT THEY SEE A GREEN LIGHT ON THE DOCK, BUT IT DOESN'T STAY ON UNLESS THEY HOLD THE RECHARGER CORD, AND THE RECHARGER ONLY SHOWS A FLASHING LIGHT ON THE BATTERY INDICATOR BUT IT DOES NOT POWER ON. AGENT HAD THE PATIENT RESET THE RECHARGER ON/OFF THE DOCK, BUT IT STILL WOULD NOT POWER ON. THE CHARGING PORT IS SOMEHOW LOSE, AND THEY HAVE TO HOLD THE CHARGER. AGENT REQUESTED A REPLACEMENT THROUGH REPAIR. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURING REP STATING THEY BEGAN ATTEMPTING TO START A PHYSICIAN RECHARGING SESSION AND WAS NOT ABLE TO GET THE RECHARGER BUTTON PRESS SEQUENCE CORRECT. DURING THE CALL THE CALLER WAS ABLE TO START THE RECHARGE SUCCESSFULLY. THE CALLER WILL WORK WITH THE PATIENT TO CONTINUE CHARGING THE INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647005 ↗
• MalfunctionMar 19, 2026Disconnection; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF PARKINSON'S DISEASE UNDERWENT DEEP BRAIN STIMULATION. THE SURGICAL SITE FOR A BRAIN TUMOR OVERLAPPED WITH THE LEAD PLACEMENT, WHICH DAMAGED THE CONNECTION BETWEEN THE LEAD AND THE EXTENSION. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641689 ↗
• MalfunctionMar 18, 2026Delayed Charge Time

  IT WAS REPORTED THAT IT SEEMS LIKE EVERY TIME THE PATIENT GOES TO CHARGE, IT IS TAKING FOREVER TO CHARGE THE IMPLANT. PATIENT SAID IT NEVER USED TO TAKE THAT LONG. PATIENT WAS SENT A NEW HANDSET ABOUT A YEAR AGO. PATIENT HAS 2 IMPLANTS AND BOTH TAKE 2 HOURS TO CHARGE. PATIENT THINKS ONE IMPLANT TAKES A LITTLE LESS TIME TO CHARGE BUT IT IS ONLY A FEW MINUTES. PATIENT USED TO CHARGE FOR 40-45 MINUTES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT SAID THEY HAVEN'T HAD ANY RECENT REPROGRAMMING. PATIENT SAID WHEN THEY RUB THE RIGHT SIDE OF THEIR HEAD THEIR LEFT ARM GOES NUMB. PATIENT SAID THEIR SYMPTOMS ARE WORSE ON THE LEFT SIDE. SEE (B)(4) FOR WIRELESS RECHARGER ISSUE.

  Patient problems: Numbness

  MAUDE report 24629842 ↗
• MalfunctionMar 18, 2026Delayed Charge Time

  IT WAS REPORTED THAT IT SEEMS LIKE EVERY TIME THE PATIENT GOES TO CHARGE, IT IS TAKING FOREVER TO CHARGE THE IMPLANT. PATIENT SAID IT NEVER USED TO TAKE THAT LONG. PATIENT WAS SENT A NEW HANDSET ABOUT A YEAR AGO. PATIENT HAS 2 IMPLANTS AND BOTH TAKE 2 HOURS TO CHARGE. PATIENT THINKS ONE IMPLANT TAKES A LITTLE LESS TIME TO CHARGE BUT IT IS ONLY A FEW MINUTES. PATIENT USED TO CHARGE FOR 40-45 MINUTES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT SAID THEY HAVEN'T HAD ANY RECENT REPROGRAMMING. PATIENT SAID WHEN THEY RUB THE RIGHT SIDE OF THEIR HEAD THEIR LEFT ARM GOES NUMB. PATIENT SAID THEIR SYMPTOMS ARE WORSE ON THE LEFT SIDE. SEE (B)(4) FOR WIRELESS RECHARGER ISSUE.

  Patient problems: Numbness

  MAUDE report 24626583 ↗
• InjuryMar 16, 2026Failure to Deliver Energy

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR 4 DAYS AFTER BEING IN THE ER. CALLER SAID THE IMPLANTABLE NEUROSTIMULATOR (INS) SHUT OFF INADVERTENTLY WHICH CAUSED THE EMERGENCY. CALLER SAID THE PATIENT IS USUALLY MOBILE. CALLER SAID THE PATIENT HAD A SUDDEN RAPID DROP AND WITHIN 24 HOURS HE WAS BEDRIDDEN. CALLER SAID THEY DISCOVERED THE INS WAS OFF AND WHEN THE PATIENT TURNED BACK ON HIS MOTOR FUNCTION CAME BACK. CALLER SAID THE INS NEVER DEPLETED AND REMAINED AT 75%. CALLER SAID THE INS SHUT OFF SOMETIME BETWEEN (B)(6) 2025 AND THIS PAST WEEKEND. CALLER SAID IN (B)(6) OR (B)(6) OF 2025 THE PATIENT STARTED COMPLAINING OF A PULLING SENSATION IN HIS FACE BUT CALLER SAID IT WAS NOT VISIBLE TO HER. CALLER SAID AT 1ST THEY SAID IT WAS DYSTONIA BUT THE PATIENT SAID IT WAS DIFFERENT FROM DYSTONIA. CALLER SAID THE PATIENT A CT SCAN AND THEIR BRAIN IMAGED. CALLER SAID WHEN THE PATIENT TURNED STIM BACK ON WHEN THEY WERE IN HOSPITAL THE PULLING GOT WORSE AND IT WAS VISIBLE TO THE CALLER, CALLER SAID IT LOOKED LIKE SOMEONE HAD A HOOK IN THE SIDE OF THE PATIENT'S MOUTH AND WAS PULLING ON THE HOOK. CALLER SAID THEY HAVE AN APPOINTMENT W/ HEALTHCARE PROVIDER (HCP) COMING UP.

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity

  MAUDE report 24611475 ↗
• MalfunctionMar 10, 2026Failure to Power Up; Charging Problem

  IT WAS REPORTED THAT THE RECHARGER IS NOT CHARGING. PATIENT STATES RECHARGER WILL NOT TURN ON AT ALL. PATIENT MENTIONED BATTERY LIGHT NEVER COMES ON. PATIENT HAS HAD RECHARGING IN THE DOCK OVERNIGHT AND THE DOCK HAS A GREEN LIGHT ON IT. AGENT HAD PATIENT RESET RECHARGER ON AND OFF THE DOCK. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGER AND DOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555500 ↗

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.