Activa® RC 37612 (UDI 00763000519247)Recalls & reported problems

Summary

The FDA's MAUDE database contains 371 adverse event reports that list this exact device (DI 00763000519247), received between Feb 7, 2022 and Sep 22, 2026 — classified as 2 deaths, 112 injuries, 257 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (80 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 371 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860501 ↗
• InjurySep 17, 2026Failure to Deliver Energy

  Patient problems: Fall

  MAUDE report 50811366 ↗
• DeathAug 24, 2026Failure to Deliver Energy; Battery Problem; Charging Problem

  It was reported that the pt's nursing facility had been very inappropriate in a lot of ways and one of the ways in which they were i nappropriate was specifically having to do with the device/therapy: the caller stated the nursing home attested again and again that they'd kept pt's DBS therapy fully charged at all times and that they would charge the pt's INS every other day for 15 minutes each time which fully charged however the caller said that couldn't be true because they'd always charged the pt and it always had taken longer. Patient Services (PS) reviewed that it would typically take an hour of charging per quarter of the battery. Caller said when the pt's DBS therapy was ON, pt would have NO tremor and that people had never known the pt had stage 4 Parkinson's however the visiting nurses' notes from the facility indicated pt constantly had violent tremor. Caller said whenever they visited they would check the implantable neurostimulator (INS) battery levels and inevitably found the INS battery was fully depleted and it was OFF.  Caller said they would reach out to the pt's HCP to get more information but they hoped that they could be sent labeling pointing to the amount of

  Patient problems: Dehydration; Encephalopathy; Fall; Insufficient Information; Multiple Organ Dysfunction Syndrome; Muscle Weakness/Atrophy; Pain; Shaking/Tremors; Syncope/Fainting

  MAUDE report 50406997 ↗
• InjuryAug 23, 2026Failure to Deliver Energy; Battery Problem

  The patient provided additional information indicating that the device turned off because it had gone too many days without charging. The patient charged the device, and the issue was resolved.

  Patient problems: Shaking/Tremors

  MAUDE report 50397019 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with Parkinson¿s disease was treated with an implanted deep brain stimulation system. Postoperatively, there was no therapeutic effect and persistent high muscle tone. Communication with the physician regarding subsequent treatment occurred. In 2025, the entire system was explanted due to the reported lack of efficacy. The issue was reported as resolved. The patient was alive with no injury.

  Patient problems: Muscular Rigidity

  MAUDE report 50305917 ↗
• InjuryAug 17, 2026Improper or Incorrect Procedure or Method; Battery Problem

  It was reported that manufacturing rep is going to see the patient tomorrow to recover implantable neurostimulator (INS)  from over discharge for for an MRI and wanted to know if there was a way to know how many times the implanted neurostimulators had been physician reset without attempting to do it. Caller stated that the patient is a chronic noncompliant and has not maintained the charge of her battery. Caller mentioned that they had done one physician reset on the patient a few years ago and called tech services to help walk them through it. Agent asked caller when the patient attempted to charge and could not, caller did not know. The issue was not resolved through troubleshooting. Agent reviewed considerations around recovery of the INS, MRI. Pt currently sedated in ICU. The rep indicated that they attempted one reset on each of the patient's INS, they have been unable to get the rechargers to connect for normal charging at the time of the call. The caller asked for information about charging an INS and the recovery process. Provider at the care facility inquired about turning therapy off or putting system into MRI mode. Per caller, Rep was able to charge the implant last nig

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50282201 ↗
• InjuryJul 30, 2026Failure to Deliver Energy; Delayed Charge Time; Battery Problem; Communication or Transmission Problem

  It was reported that yesterday, the patient's therapy unexpectedly shut off. They felt numb on the side of their face and started shaking. They got the recharger and spent a lot of time charging because it was difficult to get connected to recharge. So they went to the hospital/emergency room (ER) to get things checked out and due to increased tremor. The patient was hospitalized due to lack of charge. They were told that they did not think it was too low. However, it was also noted that the patient's battery ran out of charge. Once they discovered it was off, they turned it back on. The patient noticed sensation when it was OFF and back ON. The sensation went away and this has happened to them in the past 3 times where they felt that sensation. They wanted to prevent therapy turning off in the future and provided product suggestion. The potential for therapy to turn off if the INS battery got too low was reviewed. The patient stated that they do not let the battery get low. They charge 3 times a week for an hour or more. They recently have not been checking because the equipment all needs to get plugged in and they have a lot of things to plug in. During the call, the patient used

  Patient problems: Insufficient Information; Numbness; Shaking/Tremors

  MAUDE report 50082450 ↗
• MalfunctionJul 2, 2026Failure to Deliver Energy

  IT WAS REPORTED THAT PATIENT (PT) IS HAVING TROUBLE WITH THEIR COMMUNICATOR SINCE YESTERDAY. PATIENT STATED THEIR IMPLANT IS OFF AND THEY WANT TO TURN IT BACK ON BUT THEIR COMMUNICATOR WILL NOT TURN ON. PATIENT CONFIRMED ON THE CALL THE COMMUNICATOR POWERED ON. AGENT WALKED PATIENT THROUGH STEPS TO CONNECT WITH THEIR IMPLANT. PATIENT INITIALLY GOT NO DEVICE RESPONSE WHEN TRYING TO CONNECT WITH THEIR IMPLANTED NEUROSTIMULATOR. PATIENT REPOSITIONED COMMUNICATOR ON THEIR IMPLANT AND CONFIRMED SUCCESSFULLY CONNECTED WITH THEIR IMPLANT. PATIENT STATED THERAPY WAS OFF. PATIENT THEN STATED THEY SAW NO DEVICE RESPONSE AGAIN WHEN TRYING TO TURN THERAPY ON. AGENT REVIEWED TO ENSURE COMMUNICATOR WAS STILL OVER PATIENT'S IMPLANT. PATIENT CONFIRMED COMMUNICATOR WAS ON THEIR IMPLANT AND CONFIRMED SUCCESSFULLY TURNED THERAPY ON. PATIENT REPORTED ONCE TURNED THERAPY ON THAT THEIR VOICE WAS "DIFFERENT" AND STATED THEIR VOICE IS DIFFERENT FOR A FEW SECONDS WITH TURNING THERAPY ON. PATIENT STATED IT FELT LIKE A "RUSH" (AGENT UNABLE TO MAKE OUT WHAT ELSE PATIENT SAID AT THIS POINT IN THE CALL). PATIENT LATER CONFIRMED THEY WERE FEELING BETTER DURING THE CALL FOLLOWING TURNING THERAPY ON. PATIENT CONFI

  Patient problems: Insufficient Information

  MAUDE report 25694819 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem; Charging Problem

  IT WAS REPORTED THAT ABOUT AN HOUR AND A HALF AGO WHEN PATIENT WENT TO CHARGE THE IMPLANTED NEUROSTIMULATOR, THE LIGHTS ON THE RECHARGER STARTED FLASHING UP AND DOWN RAPIDLY. CALLER SAID THAT THE CHARGER WILL NOT CHARGE THE IMPLANT AND WON'T RECHARGE WHEN IN THE DOCK. WHEN ASKED, CALLER SAID THAT THEY STORE THE RECHARGING EQUIPMENT IN THE CASE BESIDE THE AC POWER SUPPLY. REVIEWED GENERAL MAINTENANCE INFORMATION. REVIEWED TROUBLESHOOTING STEPS: INSTRUCTED CALLER TO PLACE THE CHARGER IN THE DOCK AND PRESS AND HOLD DOWN THE POWER BUTTON FOR ABOUT 5 SECONDS. CALLER CONFIRMED THAT THE GREEN LIGHT IS ON THE DOCK HOWEVER THE LIGHTS ARE STILL FLASHING. NEXT CALLER PERFORMED RECHARGER RESET HOWEVER THAT DIDN'T RESOLVE THE ISSUES EITHER. CALLER TRIED ANOTHER DOCK AND TRIED ANOTHER RESET HOWEVER THE SAME THING HAPPENED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664139 ↗
• MalfunctionJun 23, 2026Display or Visual Feedback Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO CHARGE THE IMPLANTED NEUROSTIMULATOR AND THE RECHARGER WAS CHARGED. THEY KEEP IT PLUGGED IN ALL THE TIME SO IT SHOULD HAVE BEEN FULLY CHARGED. WHEN THEY WENT TO CONNECT ALL IT WAS DOING WAS THREE LITTLE SQUARES ON THE TOP AND THE FLASHING LIGHT WAS GOING FROM ONE TO THE OTHER. IT WAS NOT SOLID AND IT WOULDN'T CHARGE. THE GREEN LIGHTS WERE SCROLLING WHEN THEY TOOK IT OUT OF THE DOCK. THE ISSUE STARTED TODAY. ON THE CALL HAD CALLER DO A HARD RESET ON THE RECHARGING DEVICE. THE LIGHTS WERE STILL SCROLLING. A MESSAGE WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE WIRELESS RECHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594276 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYMPTOMS WERE NOT WELL CONTROLLED. SYSTEM EXPLANT IS PLANNED FOR (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 25280243 ↗
• InjuryMay 19, 2026Energy Output Problem

  IT WAS REPORTED THAT THERE WAS ALLEGED ELECTROMAGNETIC LEAKAGE FROM THE CHEST POCKET. THE STIMULATOR WAS EXPLANTED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. THE ISSUE WAS REPORTED AS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221891 ↗
• MalfunctionMay 18, 2026Display or Visual Feedback Problem; Charging Problem

  IT WAS REPORTED THAT THE RECHARGER IS NOT CHARGING THE IMPLANTED NEUROSTIMULATOR. THE ISSUE STARTED LAST NIGHT AT 9PM. THE GREEN LIGHT IS ILLUMINATED ON THE DOCKING STATION. WHEN THEY PUT THE RECHARGING DEVICE ON THE DOCK THEY ARE GETTING A SCROLLING LIGHT. ON THE CALL HAD PATIENT DO A HARD RESET OF THE DEVICE. CONFIRMED THEY ARE USING THE THICK WHICH CHARGING CABLE. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL DID NOT RESOLVE THE ISSUE. A MESSAGE WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGER. SENT EMAIL TO PATIENT REGISTRATION TO UPDATE PATIENT ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204057 ↗
• MalfunctionMay 11, 2026Battery Problem; Charging Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING A CHARGE FREQUENCY ISSUE. THEY STATED THAT IT DOESN'T SEEM LIKE THE IMPLANT KEEPS A GOOD CHARGE. CALLER STATED THEY CHARGED A "WHOLE BUNCH" YESTERDAY AND TODAY THE IMPLANT IS NOW DEAD. CALLER PLACED THE WIRELESS RECHARGER OVER THEIR IMPLANTABLE NEUROSTIMULATOR (INS)  AND THEY CONNECTED SUCCESSFULLY RIGHT AWAY. CALLER DID NOT HAVE THEIR HANDSET WITH THEM AT THE TIME OF THE CALL (COULD NOT CHECK CHARGE QUALITY). CALLER WILL CALL BACK WITH EQUIPMENT FOR FURTHER TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137961 ↗
• MalfunctionMay 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT USING THE WIRELESS RECHARGER FOR A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR EXPERIENCED SCROLLING BATTERY LIGHTS ON THE RECHARGER. THE GREEN LIGHT WAS ILLUMINATED ON THE DOCK. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING, WHICH INCLUDED REVIEWING HOW TO RESET THE DEVICE. A REQUEST WAS SENT TO REPAIR AND REPLACE THE RECHARGER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076941 ↗
• MalfunctionMay 4, 2026Improper or Incorrect Procedure or Method; Battery Problem

  IT WAS REPORTED THAT PATIENT HAD TURNED THEIR DBS THERAPY OFF PER THEIR PHYSICIAN'S INSTRUCTIONS AND HAD NOT CHARGED FOR ABOUT A YEAR. NOW PATIENT IS IN NEED OF MRI AND WHEN THEY WENT TO ATTEMPT TO CHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) THEY ENCOUNTERED ERROR CODE 1713. REVIEWED MEANING OF THIS CODE AND EXPECTATIONS REGARDING OVERDISCHARGE. REDIRECTED TO MANAGING PHYSICIAN FOR PHYSICIAN MODE RECHARGE AND MRI ELIGIBILITY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071675 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S FAMILY REPORTED A POSTOPERATIVE INFECTION AT THE POSTAURICULAR LEAD SITE, AND THE ENTIRE DEVICE SYSTEM WAS EXPLANTED IN (B)(6) 2025. PATIENT RECEIVED A NEW IMPLANTABLE NEUROSTIMULATOR SYSTEM IN (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 25061987 ↗
• MalfunctionApr 27, 2026Intermittent Continuity; Failure to Deliver Energy; Charging Problem

  IT WAS REPORTED THAT FOR A FEW MONTHS NOW, THEY HAVE BEEN HAVING A HARD TIME RECHARGING THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) . CALLER REPORTED THAT THE RECHARGER WOULD KEEP BEEPING LIKE IT WAS FINDING THE INS AND THEY WOULD BE ABLE TO INTERMITTENTLY CHARGE THE INS UNTIL 50% BUT WOULD STOP THERE BECAUSE THE PATIENT WOULD BE ANNOYED BY THE BEEPING SOUND OF THE RECHARGER. CALLER ALSO MENTIONED THAT THEY WOULD NOTICE THAT FOR QUITE A FEW TIMES NOW, THE THERAPY WOULD TURN OFF BY ITSELF EVEN WHEN THE INS BATTERY WOULD STILL BE AT 50%. CALLER STATED THAT SOMETIMES THEY WOULD NOTICE THAT THE PATIENT'S SYMPTOMS WOULD COME BACK AND WHEN THEY GO TO CHECK THE THERAPY, THEY WOULD SEE THAT IT WOULD BE OFF, AND THEY DO NOT KNOW WHY THE THERAPY TURNS OFF BY ITSELF. CALLER STATED THAT THE PATIENT DID NOT HAVE ANY RECENT FALLS LATELY AND THE PATIENT WAS NOT EXPOSED TO EMI. CALLER ALSO STATED THAT THE RECHARGER WOULD NOT CAUSE ANY ERROR TONES OR SHOW ANY ERROR MESSAGES ON THE HANDSET. AGENT REVIEWED THAT THE RECHARGER SEEMED TO BE WORKING AS EXP ECTED. AGENT REDIRECTED PATIENT TO THEIR HCP TO FURTHER ADDRESS THE ISSUE. CALLER STATED THAT THEY WERE AT THEIR PATIENT'S HCP YESTERDAY FOR BOTOX

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 25001047 ↗
• MalfunctionApr 23, 2026Failure to Interrogate; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT THE 'NOT FOUND COMMUNICATOR' SCREEN RESURFACED SEVERAL HOURS AFTER THEY LAST SPOKE WITH PATIENT SERVICES. THE PATIENT CONFIRMED LOCATION WAS STILL TURNED ON. THE PATIENT CONFIRMED THE COMMUNICATOR WAS CLOSE TO THE HANDSET (1 FOOT AWAY), COMMUNICATOR WAS CHARGED, AND THEY WERE IN THE SAME ROOM THEY ALWAYS USE THE COMMUNICATOR. NO SOURCES OF EMI WERE PRESENT. THE PATIENT MENTIONED THAT THEY HAD BEEN RESTARTING THE HANDSET TO RESOLVE THE PAIRING ISSUE, BUT THAT WASN'T WORKING EITHER. THE PATIENT CONTINUED TO GET THE 'NOT FOUND COMMUNICATOR' SCREEN DURING THE CALL. AGENT REVIEWED THAT A REPLACEMENT COMMUNICATOR WOULD BE REQUESTED, BUT THE PATIENT INSISTED ON HAVING BOTH THE COMMUNICATOR AND HANDSET REPLACED SO THEY COULD HAVE PEACE OF MIND. AGENT RE-OPENED THE CASE AND SENT A REQUEST TO THE REPAIR DEPARTMENT TO REPLACE THE COMMUNICATOR AND HANDSET. AGENT REVIEWED INFORMATION ABOUT INS LONGEVITY. PATIENT MENTIONED THEIR DBS THERAPY WAS INDICATED FOR TOURETTE'S. THE PATIENT MENTIONED THAT EKG MACHINES WON'T WORK IF THERAPY STAYS ON, SO THEY TURN THERAPY OFF BEFORE EKGS. THE PATIENT CALLED BACK REPORTING THEY GOT REPLACEMENT PROGRAMMER AND COMMUNICATOR. PATIENT HAD SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964811 ↗
• InjuryApr 23, 2026Failure to Deliver Energy; Battery Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER SAID THAT THE PATIENT HAD A COMPLETE MELTDOWN ABOUT 6 WEEKS AGO AND THEY HAD TO TAKE THE PATIENT TO THE EMERGENCY ROOM. CALLER SAID THE PATIENT WAS THERE FOR A WEEK AND NO ONE SEEMS TO KNOW WHAT IS GOING ON WITH THE PATIENT'S DBS INS. CALLER ALSO SAID THAT PATIENT IS IN A NURSING HOME RIGHT NOW, CALLER HAS NOT BEEN ABLE TO FIGURE OUT CURRENT HCP. CALLER STATED THAT PATIENT HAS THE RECHARGER BUT NOT THE DOCK OR HANDSET. CALLER STATED THEY DID FIND A COMMUNICATOR WHEN CLEANING PATIENTS HOUSE AND THINK THEY WERE ABLE TO CHARGE THE COMMUNICATOR. CALLER STATED PATIENT IS NOT FEELING GOOD AND IS FEELING WEAK AND IS CONCERNED ABOUT THEIR THERAPY. CALLER DID NOT HAVE THE RECHARGING EQUIPMENT WITH THEM AT THE TIME OF THE CALL. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DEVICES. CALLER WILL CALL BACK ONCE THEY HAVE THE EQUIPMENT FOR FURTHER ASSISTANCE. PT REP CALLED AND REQUESTED SUPPORT TO PAIR THE HANDSET TO THE CHARGER AND CALLER WAS SUCCESSFUL TO START CHARGING THE PATIENT'S INS BATTERY. CALLER SAID THEY GOT AN EXCELLENT CO

  Patient problems: Convulsion/Seizure; Insufficient Information; Muscle Weakness/Atrophy; Syncope/Fainting

  MAUDE report 24964146 ↗
• MalfunctionApr 17, 2026Malposition of Device; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT STATED THEY HAD BEEN EXPERIENCING DIFFICULTY OVER THE PAST SEVERAL MONTHS WITH THE RECHARGER CONNECTING TO THE IMPLANTED NEUROSTIMULATOR. THE PATIENT REPORTED FEELING THE DEVICE IN THE CHEST AND STATED THAT THE CONNECTION WAS INTERMITTENT, SOMETIMES REQUIRING REPEATED REPOSITIONING, AND THAT APPLYING PRESSURE TO THE RECHARGER WAS NEEDED TO ACHIEVE COUPLING. THE PATIENT REPORTED NOTICING THAT ONE CORNER OF THE IMPLANT WAS MORE PROMINENT SHORTLY AFTER IMPLANTATION AND THAT IT HAD SINCE SETTLED, THOUGH IT REMAINED PALPABLE BENEATH THE SKIN. THE PATIENT STATED THEY TYPICALLY RECLINED DURING CHARGING, ALIGNED THE RECHARGER OVER THE IMPLANT, AND EXPERIENCED INTERMITTENT DISCONNECTIONS REQUIRING READJUSTMENT. THE PATIENT DENIED ANY RECENT FALLS. A RECHARGER RESET WAS PERFORMED DURING THE CALL, BUT IT DID NOT RESOLVE THE ISSUE. THE WIRELESS RECHARGER IS GOING TO BE REPLACED. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918280 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SMALL SWELLING WITH PURULENT DISCHARGE APPEARED AT THE POSTAURICULAR LEAD SITE IN (B)(6) 2025. DEBRIDEMENT WAS PERFORMED IN (B)(6) 2025, AFTER WHICH PURULENT DISCHARGE RECURRED. IN (B)(6) 2026, THE ENTIRE DEVICE WAS EXPLANTED AT THE HOSPITAL.

  Patient problems: Purulent Discharge

  MAUDE report 24873053 ↗
• MalfunctionApr 13, 2026Failure to Deliver Energy; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN UNABLE TO CHARGE THE IMPLANT SINCE (B)(6), THE PREVIOUS WEEK, AND PRESENTED FOR EVALUATION. AT THAT TIME, THE DEVICE WAS FOUND TO BE TURNED OFF DESPITE A REPORTED BATTERY LEVEL OF 25%. THE CALLER SAID THE PATIENT REQUIRED EMERGENCY ROOM EVALUATION OVER THE WEEKEND DUE TO THE INABILITY TO MOVE. IT WAS NOTED THAT THE PATIENT HAD CONTACTED A MANUFACTURER REPRESENTATIVE REGARDING THE REPLACEMENT OF THE RECHARGER. STILL, IT WAS ADVISED THAT A NEW DEVICE COULD NOT BE ISSUED UNTIL THE REQUIRED DOCUMENTATION WAS COMPLETED, WHICH HAD NOT YET BEEN RECEIVED. PATIENT SERVICES CONFIRMED DURING THE CALL THAT THE PATIENT HAD THE APPROPRIATE EQUIPMENT FOR CHARGING THE IMPLANT, AND DURING TROUBLESHOOTING, THE CALLER CONNECTED TO THE IMPLANT AND VERIFIED THAT CHARGING WAS OCCURRING. THE HEALTHCARE PROFESSIONAL REACTIVATED THERAPY AND CONFIRMED THAT THE BATTERY HAD DEPLETED ON THE (B)(6), WHICH RESULTED IN THERAPY BEING TURNED OFF. THE ISSUE WAS RESOLVED FOLLOWING TROUBLESHOOTING, AND THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER FOR FURTHER EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM PATIENT REPRESENTATIVE INDICATING THAT NOW THE IMPLANT WAS 100

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24853629 ↗
• MalfunctionApr 9, 2026Delayed Charge Time; Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE RECHARGER CHARGE DOES NOT LAST AS LONG. PATIENT IS SEEING A LOW BATTERY SCREEN ON THE PROGRAMMER BUT IS NOT SURE IF IT WAS THE IMPLANT CHARGE OR RECHARGER CHARGE. PATIENT DID MENTION THE IMPLANT BATTERY DID GET TO AROUND 25% BUT ALSO MENTIONED THE RECHARGER WAS FULLY CHARGED WITH THREE GREEN LIGHTS AND THEN A COUPLE DAYS LATER IT HAD ONE LIGHT. AGENT REVIEWED IF THE PATIENT WAS RECHARGING THEIR IMPLANT THE GREEN BATTERY LIGHTS ON THE RECHARGER MAY GO DOWN. PATIENT STATES IT SEEMS LIKE IT TAKES FOREVER TO GET THE LAST 25% CHARGED. AGENT REVIEWED THIS CAN BE NORMAL . PATIENT WILL MONITOR AND CALL BACK IF ISSUE PERSISTS. ADDITIONAL INFO RECEIVED FROM PATIENT THAT THEY HAVE BEEN HAVING TROUBLE CHARGING THEIR STIMULATOR. THEY SAID THEY HAVE CALLED SEVERAL TIMES ABOUT IT. THE PATIENT HAS THE WIRELESS RECHARGER. THEY SAID IT DOESN'T COME ON LIKE IT ONCE DID. LAST NIGHT THEY LET THE BATTERY RUN DOWN BECAUSE THEY WERE DIZZY. THEY WERE PRETTY LOW. THEY SAID IT TOOK FOREVER TO GET TO 25%. THE PATIENT WAS SAYING THEY WOULD LOSE CONNECTION AND WOULD HAVE TO REPOSITION IT. PATIENT NORMALLY GETS GOOD AN EXCELLENT CONNECTION. AGENT REVIEWED WHEN IT IS ON GOOD CONNECTION TH

  Patient problems: Dizziness

  MAUDE report 24827693 ↗
• 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'S

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

  MAUDE report 24793113 ↗

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.