Activa® RC 37612 (UDI 00763000100360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 469 adverse event reports that list this exact device (DI 00763000100360), received between Mar 3, 2020 and Sep 28, 2026 — classified as 1 death, 89 injuries, 379 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (114 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 469 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem

  Patient problems: Electric Shock; Paresthesia

  MAUDE report 50924442 ↗
• MalfunctionSep 28, 2026Device Difficult to Program or Calibrate; Therapeutic or Diagnostic Output Failure

  It was reported that patient went to orchestra rehearsal at lunchtime today and turned up the stimulation to have better tremor control. When rehearsal was over, patient went to turn the stimulation down and received a symbol on the programmer with a doctor on it telling patient to call their doctor. Patient said that has tried several times and continues to get the message. When asked, patient does have her programmer with her at the time of the call. Patient connected and reviewed call doctor screen and said OOR was listed below. Reviewed meaning of the message and with instruction patient was able to connect to implant and get beyond the screen and lowered the setting. The troubleshooting steps that were taken on the call resolved the issue. Patient to monitor if this occurs after increases again and if so, patient was directed to report to their managing physician. Patient called back regarding previously reported events. Patient stated that their "remote control" could not turn their DBS off, and they are encountering a screen with a doctor and said OOR. Agent tried to have them decrease and increase the stimulation but the issue persists. Agent redirected them to the HCP to f

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916600 ↗
• InjurySep 16, 2026Failure to Deliver Energy

  Patient problems: Memory Loss/Impairment

  MAUDE report 50794607 ↗
• MalfunctionAug 28, 2026Material Frayed; Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495349 ↗
• InjuryAug 23, 2026Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

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

  MAUDE report 50397470 ↗
• MalfunctionAug 17, 2026Display or Visual Feedback Problem; Battery Problem; Charging Problem

  It was reported that recharger has died and does not make any noise. When they put it on the charging dock the battery light scrolls rapidly. Patient reported they had emailed rep yesterday about this and attempted a hard reset but this did not resolve the scrolling battery light. Patient also noted that they have to hold the cord at an angle in the dock to get it to work. The charging port is loose. Patient was not certain if the micro USB dock cable was the issue or the port on the dock. The recharger is not holding a charge and not charging their implanted device". Agent had them plug the recharging dock on the wall, and had the wireless recharger sit on it. Caller stated that when they hold the dock upright, the scrolling green battery light comes up on the recharger, but there are no lights when it's flat. Agent had them reset the recharger but it stayed unresponsive out off the dock, and with a scrolling green light when on the dock. Caller also stated that when they move the dock around, the charger port seemed a little loose, the green light on the dock goes out whenever it's moved when sitting on the floor, and it only goes on when the dock is sitting upright. Agent reques

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269918 ↗
• MalfunctionJul 15, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Chest Pain; Electric Shock

  MAUDE report 25832142 ↗
• MalfunctionJun 24, 2026High impedance; Unintended Collision; Low impedance

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR PROGRAMMING TODAY AND THE LEFT LEAD HAS OPEN IN SHORTS ON THE ENTIRE THING AND THE RIGHT CONTACT NUMBER 8 IS SHOWING POTENTIAL SHORT. CURRENTLY THE PATIENT IS GETTING THERAPY WITH PROGRAMMING ON THE LEFT LEAD USING C+ 2-. THE PATIENT HAS HAD MULTIPLE FALLS ALMOST EVERY DAY. THE CALLER DID NOT KNOW WHEN THE FALLS STARTED AND THE IMPEDANCE ISSUE WAS DISCOVERED DURING THE PROGRAMMING SESSION TODAY.

  Patient problems: Fall

  MAUDE report 25609734 ↗
• MalfunctionJun 12, 2026Display or Visual Feedback Problem; Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT¿S REPRESENTATIVE STATING THE PATIENT WAS EXPERIENCING SHAKING ON BOTH S IDES AND THAT WHEN ATTEMPTING TO CHECK THERAPY WITH THE PATIENT PROGRAMMER, AN UNFAMILIAR SCREEN WAS DISPLAYED DESPITE REPLACING THE PROGRAMMER BATTERIES MULTIPLE TIMES. THE REPRESENTATIVE REPORTED THAT THE SYMPTOMS BEGAN SEVERAL DAYS EARLIER. THE CALLER DESCRIBED SEEING AN OVER-DISCHARGED SCREEN. PSS REVIEWED THE MESSAGE'S MEANING. DURING THE CALL, THE PATIENT REPRESENTATIVE CONNECTED THE IMPLANTED NEUROSTIMULATOR TO THE WIRELESS RECHARGER AND OBSERVED THAT CHARGING WAS OCCURRING ON ONE SIDE. THE AGENT REVIEWED FOR THE PATIENT TO CONTINUE CHARGING. THE PATIENT'S REPRESENTATIVE CALLED BACK FOR ASSISTANCE TO TURN THE PATIENT'S (PT) THERAPY BACK ON. THE CALLER SAID THEY TRIED TO CHARGE, THE STIMULATORS WOULD CHARGE FOR A FEW SECONDS, THEN MAKE THE FULLY CHARGED TONES. THE CALLER USED THE PROGRAMMER TO CHECK BOTH IMPLANTS AND CONFIRMED THAT THE LEFT-SIDE INS DISPLAYED A LOW-BATTERY SCREEN WITH THERAPY OFF, WHICH WAS SUCCESSFULLY TURNED ON, WHILE THE RIGHT-SIDE INS CONTINUED TO DISPLAY AN OVER-DISCHARGED SCREEN. THE REPRESENTATIVE WAS ADVISED TO CONTINUE

  Patient problems: Shaking/Tremors

  MAUDE report 25488355 ↗
• MalfunctionJun 12, 2026Display or Visual Feedback Problem; Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT¿S REPRESENTATIVE STATING THE PATIENT WAS EXPERIENCING SHAKING ON BOTH S IDES AND THAT WHEN ATTEMPTING TO CHECK THERAPY WITH THE PATIENT PROGRAMMER, AN UNFAMILIAR SCREEN WAS DISPLAYED DESPITE REPLACING THE PROGRAMMER BATTERIES MULTIPLE TIMES. THE REPRESENTATIVE REPORTED THAT THE SYMPTOMS BEGAN SEVERAL DAYS EARLIER. THE CALLER DESCRIBED SEEING AN OVER-DISCHARGED SCREEN. PSS REVIEWED THE MESSAGE'S MEANING. DURING THE CALL, THE PATIENT REPRESENTATIVE CONNECTED THE IMPLANTED NEUROSTIMULATOR TO THE WIRELESS RECHARGER AND OBSERVED THAT CHARGING WAS OCCURRING ON ONE SIDE. THE AGENT REVIEWED FOR THE PATIENT TO CONTINUE CHARGING. THE PATIENT'S REPRESENTATIVE CALLED BACK FOR ASSISTANCE TO TURN THE PATIENT'S (PT) THERAPY BACK ON. THE CALLER SAID THEY TRIED TO CHARGE, THE STIMULATORS WOULD CHARGE FOR A FEW SECONDS, THEN MAKE THE FULLY CHARGED TONES. THE CALLER USED THE PROGRAMMER TO CHECK BOTH IMPLANTS AND CONFIRMED THAT THE LEFT-SIDE INS DISPLAYED A LOW-BATTERY SCREEN WITH THERAPY OFF, WHICH WAS SUCCESSFULLY TURNED ON, WHILE THE RIGHT-SIDE INS CONTINUED TO DISPLAY AN OVER-DISCHARGED SCREEN. THE REPRESENTATIVE WAS ADVISED TO CONTINUE

  Patient problems: Shaking/Tremors

  MAUDE report 25481316 ↗
• InjuryMay 13, 2026Migration or Expulsion of Device; Use of Device Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT CALLED REGARDING A RECHARGER. THEY ENCOUNTERED AN ERROR CODE 680 WHILE ATTEMPTING TO CONNECT TO THE DBS THERAPY APP FOR SETTING ADJUSTMENTS PRIOR TO CHARGING THE IMPLANT. THE PATIENT SUPPORT SPECIALIST (PSS) INSTRUCTED THE CALLER TO EXIT THE DBS THERAPY APP AND OPEN THE RECHARGER APPLICATION. THE PATIENT SUCCESSFULLY CONNECTED TO THE RECHARGER APP AND BEGAN A CHARGING SESSION WITH A GOOD CONNECTION. THE CALLER NOTED THAT THE INS WAS AT 50%, AND MENTIONED THAT DESPITE CHARGING FOR AN HOUR, THE INS HAD REMAINED AT 25%. THE PSS REVIEWED NORMAL CHARGING DURATION TIMES WITH THE CALLER. THE PATIENT STATED THAT THEY DO NOT USE THE DRAPE WHILE CHARGING, AS IT NEVER WORKED FOR THEM, AND EXPRESSED CONCERN ABOUT WHETHER THEIR SIGNIFICANT WEIGHT LOSS MIGHT AFFECT THE CONNECTION BETWEEN THE WR AND INS, OR IF THE INS HAD MOVED. THE CALLER CONFIRMED THAT THEY COULD MAINTAIN A GOOD CHARGING CONNECTION. THE ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING. THE CALLER NOTED THEY HAD PREVIOUSLY REPLACED THE RECHARGER. THE PATIENT CALLED BACK TO REPORT THAT THEY'VE CONTINUED TO HAVE ISSUES WITH THE WR. PATIENT REPEATED THAT THEY HAD ISSUES WITH THE WR CONNECTING TO THE INS,

  Patient problems: Weight Changes

  MAUDE report 25161811 ↗
• MalfunctionMay 1, 2026Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT IMPLANTABLE NEUROSTIMULATOR (INS) IS LIKELY OVERDISCHARGED AS IT HASN'T BEEN ON/CHARGED FOR ABOUT 6-10 MONTHS AND DIDN'T CONNECT TO THE TABLET. CALLER STATED WHEN PATIENT LAST SAW MANAGING PHYSICIAN ON (B)(6) 2026, IT WOULD CONNECT THEN EITHER. TECHNICAL SERVICES WALKED CALLER THROUGH INITIATING PHYSICIAN RECHARGE MODE WITH LEGACY RECHARGER AND REVIEWED HOW TO PROCEED ONCE POWER ON RESET MESSAGE IS SHOWN AND INS IS CHARGING NORMALLY. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059925 ↗
• MalfunctionApr 22, 2026Connection Problem; Material Integrity Problem

  DEVICE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958112 ↗
• InjuryApr 20, 2026Failure to Deliver Energy; No Device Output; Delayed Charge Time

  THE HEALTHCARE PROVIDER PROVIDED ADDITIONAL INFORMATION INDICATING THAT IT'S UNKNOWN IF THE LONGER RECHARGING TIME ISSUE WAS RESOLVED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24925832 ↗
• MalfunctionApr 14, 2026Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETED AND THE PATIENT HAD BEEN SENT A NEW RECHARGER ABOUT A MONTH AGO - PT NOTICED THE INS WAS IN OVERDISCHARGE ABOUT A MONTH AGO. MANUFACTURER REPRESENTATIVE (REP) SAID TODAY THEY MET WITH THE PT AND INITIATED A PHYSICIAN RESET MODE SESSION. ALL LIGHTS AND BUTTONS APPEARED TO WORK AS EXPECTED ON RECHARGER AND RECHARGER ENTERED PHYSICIAN RESET MODE FOR ABOUT 10 MINUTES, BUT THEN RECHARGER WENT OFF AND UNRESPONSIVE. DURING THE CALL, REP. TURNED RECHARGER BACK ON AND RECHARGER APPEARED TO BE WORKING AS EXPECTED WITH 3 BATTERY LIGHTS. REP. TRIED TO CHARGE PT'S INS IN A NORMAL CHARGING SESSION, BUT LIGHT WENT AMBER AND RECHARGER MADE ERROR TONE. THEN, REP. ENGAGED ANOTHER PHYSICIAN RECHARGE SESSION. RECHARGING SESSION WORKED AS EXPECTED ON RECHARGER AND AT END OF CALL, REP. HAD THE RECHARGER OVER INS AND THE PHYSICIAN RECHARGE MODE WAS IN THE STAGE WHERE THE RECHARGER WAS TIMING FOR 60 MINUTES. TECHNICAL SERVICES SUGGESTED REP. CALL BACK IF RECHARGER EXITED PHYSICIAN RESET MODE AGAIN. THE REP CALLED BACK TO FOLLOW-UP ON THE CASE. THE CALLER INDICATED THAT THEY COMPLETED THE TROUBLESHOOTING AND CHARGED NORMALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24878675 ↗
• MalfunctionApr 6, 2026Failure to Deliver Energy

  IT WAS REPORTED THAT PATIENT LIVES AT A REHAB FACILITY AND THE STEP MOM IS THE ONLY ONE THAT HAS ACCESS TO THE HANDSET THAT CAN CHECK THE STATUS OF THE BATTERIES. CALLER STATES THE OTHER NIGHT PATIENT WAS SHAKING AND THE FOLLOWING DAY PATIENT WAS DROOLING. THE STEP MOM WENT HOME AND GOT THE CELL PHONE AND FOUND ONE SIDE WAS OFF AND WHEN THEY TURNED IT ON IT WAS AT 50% BECAUSE THE PATIENT HAD STARTED CHARGING IT . THEY WERE ABLE TO TURN THERAPY ON. CALLER STATES THEY ARE RELYING ON THE NURSES AT THE REHAB TO MAKE SURE PATIENT IS CHARGING THE IMPLANT WHICH IS A JOKE. WHEN THEY SIT THERE WITH PATIENT AND DO IT, PATIENT WILL JUST MOVE AND IT GOES OFF. THEY WANT IT TO ALMOST MAGNETIZE AND STICK BUT IT DOESN'T AND IT WILL CONSTANTLY START BEEPING AGAIN ESPECIALLY WHEN THE PATIENT IS SH AKING . CALLER IS WONDERING IF THERE IS ANYTHING ELSE THEY CAN PURCHASE . CALLER STATES IT WOULD BE EASIER TO HAVE TWO HANDSETS , ONE TO LEAVE AT THE REHAB BUT THEY ARE AFRAID IT MAY GET LOST SO WOULD NEED ONE TO KEEP IN THEIR HOME ALSO. AGENT REVIEWED THEY COULD CHECK WITH THE DOCTOR ABOUT ANOTHER HANDSET BUT UNKNOWN IF THE DOCTOR WOULD BE ABLE TO DO THAT. AGENT WILL CONTACT FIELD TO INFORM THEM. PATIENT'

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Shaking/Tremors

  MAUDE report 24793119 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT REPORTS DIFFICULTY CONNECTING TO THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AT HOME. CLINICIAN PLANNING AN IN-DEPTH PROGRAMMING SESSION IN JULY TO FURTHER INVESTIGATE. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735408 ↗
• MalfunctionMar 23, 2026Failure to Deliver Energy; Energy Output Problem; Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAS NOT BEEN ABLE TO CHARGE THEIR IMPLANT FOR "A MONTH AND A HALF" AND BELIEVES THE IMPLANT IS IN OVERDISCHARGE MODE. REPRESENTATIVE STATED THEY ARE MEETING WITH THE PATIENT AND THE PATIENT'S GRANDSON WILL BE COMING TO THE HOSPITAL IN 30-45 MINUTES TO HELP TROUBLESHOOT THE RECHARGER WITH THE EXTERNAL DEVICES. AGENT REVIEWED OVERDISCHARGE MODE AND REP PLANS TO CALL BACK IF NEEDED. REP STATES THIS STARTED A MONTH AND A HALF AGO. REP CALLED BACK STATING THEY ARE TRYING TO GET THE PATIENT TO RECHARGE AGAIN, BUT THEY ARE SUPER UNFAMILIAR WITH THE RECHARGER KIT. REVIEWED WITH THE CALLER HOW TO DO A PHYSICIAN MODE RECHARGE USING THE RECHARGER. TECHNICAL SERVICES REVIEWED TO LET THE 60 MIN TIMER RUN DOWN AND TRY NORMAL CHARGING SESSION. REVIEWED ONCE IMPLANTABLE NEUROSTIMULATOR (INS) IS CHARGED UP TO APPROX. 50%, THEY WILL NEED TO INTERROGATE INS WITH CLINICIAN PROGRAMMER APP AND CLEAR THE POR (POWER ON RESET) MESSAGE. A COUPLE MINUTES INTO IT, REP CONFIRMED THAT POR SCREEN WAS ALONG WITH NORMAL CHARGING SCREEN. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE." ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (RE

  Patient problems: Cognitive Changes; Insufficient Information; Muscular Rigidity

  MAUDE report 24665106 ↗
• MalfunctionMar 16, 2026Failure to Deliver Energy; Improper or Incorrect Procedure or Method; Battery Problem

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE DEVICE WAS SUCCESSFULLY CHARGED TO FULL AND WAS FUNCTIONING AS EXPECTED, AND THAT THE PATIENT¿S SYMPTOMS RESOLVED AND IMPROVED AFTER THERAPY WAS RESUMED.

  Patient problems: Shaking/Tremors

  MAUDE report 24603534 ↗
• MalfunctionMar 12, 2026Display or Visual Feedback Problem; Electromagnetic Compatibility Problem

  ]IT WAS REPORTED THAT THE PATIENT IS GETTING A POR (POWER ON RESET) MESSAGE ON THEIR HANDSET. THE CALLER NOTED THAT THE BATTERY IS CURRENTLY AT 100%. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE MESSAGE. DISCUSSED OVERDISCHARGE AND REVIEWED THE ONLY TIME THEY WILL NEED TO DO A JUMP START IS WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) HASN'T BEEN CHARGED FOR 30 DAYS OR MORE AND IS NOT COMMUNICATING TO PROGRAMMERS. REVIEWED OTHER POTENTIAL REASONS FOR PORS SUCH AS EMI. TECH SERVICES ASKED CALLER ABOUT ANY MEDICAL TESTING OR WORK ENVIRONMENT. THE CALLER STATED THE PATIENT HAS CANCER AND IS IN SOME KIND OF TREATMENT FOR THAT. CALLER IS MEETING THE PATIENT IN PERSON TODAY TO INTERROGATE THE BATTERY THIS AFTERNOON TO CLEAR POR MESSAGE AND CHECK THE INS. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT ADVISED THE CALLER TO HAVE THE PATIENT CONTINUE TO MONITOR THE ISSUE AND CALL BACK IF IT PERSISTS. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT POR WAS DUE TO A TIME CHANGE THAT REQUIRED BATTERY TO BE UPDATED. THIS MAY HAVE BEEN CAUSED BY INTERFERENCE FROM RADIATION THERAPY. TIME UPDATED AND POR CLEARED, PATIENT ADVISED TO TURN THERAPY OFF DURING RADIATION TREA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581013 ↗
• InjuryMar 11, 2026Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM HCP THAT THE CAUSE OF SEIZURE IS FROM A NON-EPILEPSY SEIZURE FROM PAIN. BETTER PAIN CONTROL TO RESOLVE SEIZURE ISSUES.

  Patient problems: Convulsion/Seizure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567082 ↗
• MalfunctionMar 2, 2026Display or Visual Feedback Problem; Failure to Power Up; Charging Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS MADE AWARE ON SATURDAY THAT THE PT'S RECHARGER BATTERY LIGHTS WERE FLASHING BUT RECHARGER WOULD NOT START OR CHARGE WHEN ON DOCK. THEY HAD TRIED TO CHARGE THE RECHARGER OVER THE WEEKEND, BUT THE ISSUE PERSISTED. MANUFACTURER REP. WENT TO PT'S HOME AND TRIED RESET ON RECHARGER, BUT ISSUE PERSISTED. AN REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE WIRELESS RECHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483391 ↗
• MalfunctionFeb 25, 2026Display or Visual Feedback Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT THE CAUSE OF THE RAPID BATTERY DEPLETION IS UNKNOWN. WHAT THE SESSION REPORT SAYS AND WHAT THE PATIENT IS REPORTING IS IN CONFLICT. THE PATIENT TEXTED REP WITH HIS COMPLAINT ON MONDAY, (B)(6) 2026, STATING THAT THE NIGHT PRIOR, (B)(6) 2026, HE CHARGED HIS RIGHT CHEST DBS DEVICE TO 100% AND THE NEXT DAY IT WAS READING, ¿LOW BATTERY¿. THE INTERROGATION ONLY SHOWS RECHARGING ON (B)(6) 2026, WHICH DEVICE WAS CHARGED FROM 75% TO 100% AND THE NEXT RECHARGE WAS ON (B)(6) 2026, WHICH DEVICE STARTED AT 25% AND CHARGED TO 100% OVER 3.22 HOURS. I BELIEVE HIS DEVICE WOULD HAVE DEPLETED IF NOT CHARGED FOR 10 DAYS. WITH SUSPECTED RAPID DEPLETION, REP RAN ELECTRODE IMPEDANCES AND ALSO RAN THEM WITH STRESS ON THE SYSTEM (PALPATED ON DEVICE, PALPATED ON DEVICE/EXT CONNECTION, HAD PATIENT TURN HIS HEAD TO THE RIGHT AND HOLD AND TO THE LEFT AND HOLD). NO DIFFERENCES IN IMPEDANCE VALUES WERE PRESENT WITH ANY OF THESE SCENARIOS. PATIENT REPORTS NO FALLS AND SYMPTOMS CONTROL HAS BEEN CONSISTENT AND GOOD. REPO RTED ¿RAPID BATTERY DEPLETION¿ HAS NOT OCCURRED SINCE THE DATES ABOVE. REP REPEATS PREVIOUSLY REPORTED INFORMATION INCLUDING INCONSISTENT RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442878 ↗
• MalfunctionFeb 18, 2026Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S SAID THAT THERAPY WAS NEVER OPTIMAL AND THEY WERE UNABLE TO GET RELIEF FROM DYSKINESIA AND DYSTONIA REGARDLESS OF THERAPY SETTINGS. THEIR MANAGING HEALTHCARE PROVIDER (HCP) HAD REVIEWED EXPECTATIONS WITH THEM STATING THAT THE THERAPY WAS UNABLE TO CORRECT DYSKINESIA AND DYSTONIA SIMULTANEOUSLY. PATIENT SAID THAT THE HCP SAID THAT THE INABILITY TO RESOLVE THE DYSKINESIA WAS DUE TO THE AGE OF THE IMPLANTABLE NEUROSTIMULATOR BATTERY AND LEADS NOT BEING IN OPTIMAL PLACEMENT. PATIENT SAID THEIR PARKINSON'S DISEASE HAS CONTINUED TO PROGRESS WITH WORSENING SYMPTOMS FOR AT LEAST A YEAR. THE PATIENT DESCRIBED DYSKINESIA AFFECTING THE LEFT NECK AND LEFT ARM, DYSTONIA IN MOST OF THE LEFT FOOT CAUSING THE FOOT TO TURN IN, PAIN OF UNSPECIFIED SOURCE AND LOCATION, AND BALANCE PROBLEMS. THE PATIENT REDIRECTED TO THEIR HCP TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyskinesia; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Nervous System Problem

  MAUDE report 24379041 ↗
• MalfunctionFeb 9, 2026Material Frayed; Connection Problem; Material Integrity Problem

  HAD A FRAYED DESKTOP CHARGER CORD. PATIENT FURTHER EXPLAINED AND SAID THE CONNECTOR PIN WAS A LITTLE BENT AND THE CABLE WAS STARTING TO FRAY/INSULATION WAS COMING LOOSE WHERE THE CORD MET THE PIN, AND THE WIRES WERE EXPOSED. THE PATIENT SAID THEY NOTICED THE FRAYING ISSUE THE OTHER DAY BUT THE CONNECTOR PIN BEING BENT HAD BEEN GOING ON PROBABLY SINCE 2025. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288862 ↗

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.