Activa® RC 37612 (UDI 00643169864238)Recalls & reported problems
Medtronic, Inc. · INS 37612 ACTIVA RC NO PRYLN EMN DBS ALP · Class 3 · Implant
Quick summary
This Medtronic Activa RC deep brain stimulator has 1,849 adverse event reports on record, including 2 deaths and 277 injuries. Many reports describe connection and charging problems, material integrity problems and batteries running down, with some describing a broken connector pin in the recharger and patients feeling too much stimulation. Reports fell to 102 in the last 12 months, from 168 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,849
- Deaths reported
- 2
- Injuries reported
- 276
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,849 adverse event reports that list this exact device (DI 00643169864238), received between May 10, 2018 and Sep 23, 2026 — classified as 2 deaths, 276 injuries, 1,571 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (637 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.
Reports received per month
Most reported problems
Device problems
- Connection Problem637
- Material Integrity Problem573
- Charging Problem455
- Battery Problem306
- Failure to Deliver Energy240
- Communication or Transmission Problem235
- Adverse Event Without Identified Device or Use Problem158
- Improper or Incorrect Procedure or Method118
Patient problems
- No Clinical Signs, Symptoms or Conditions1,064
- No Known Impact Or Consequence To Patient215
- Shaking/Tremors177
- Insufficient Information154
- Electric Shock88
- Ambulation or Postural Difficulties66
- Complaint, Ill-Defined57
- Unspecified Infection54
Recent adverse event reports
The 25 most recent of 1,849 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Display or Visual Feedback Problem; Battery Problem; Operating System Becomes Nonfunctional
It was reported that when they pulled the recharger out and put it on the dock, prior to starting a charging session with the implant, the green lights started scrolling rapidly. Off the dock, they said it was dead. Recharger is unresponsive on the dock. Caller said patient hadn't charged the implant in two weeks so they were hoping to get the patient charged up as soon as possible. Caller said they called they'd looked online for troubleshooting and called the manufacturer company representative this morning however both resources told them to call Patient Services (PS). PS had the caller check the status of the dock and the caller confirmed that the green light was solid when the cable was plugged in and that the light would not flicker if they moved the dock around. Patient services had the patient place the recharger on the dock and hold the power button down for ten seconds but that did not resolve. Caller took recharger off the dock and PS had the caller do a recharger reset, however the issue was not resolved through troubleshooting. Recharger maintenance considerations were reviewed with the caller and the caller said they hadn't realized they needed to always have the rech
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865555 ↗MalfunctionSep 22, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856645 ↗MalfunctionSep 21, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841224 ↗InjurySep 17, 2026Electromagnetic Compatibility Problem
It was reported that patient said their DBS therapy feels less effective when they play video games and use their washing machine. There are no known contributing factors. All impedances were checked and were in range. This issue is considered resolved.
Patient problems: Insufficient Information
MAUDE report 50802948 ↗MalfunctionSep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that caller had a frayed recharger antenna.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799106 ↗MalfunctionSep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the device was returned with no known allegation, analysis found non-conformance.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797931 ↗InjuryAug 17, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information
It was reported that patient said they have been having trouble with their head and the DBS system is acting weird. Patient said it is like there is too much current. Patient said they did discuss w/ healthcare provider (HCP) and they didn't know.
Patient problems: Electric Shock; Insufficient Information
MAUDE report 50287753 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that 9 months ago, the patient noticed a scab on their head "above the left side of the DBS." The scab on their head was checked by numerous people in those 9 months. The patient reported to the hospital to have an MRI. It was noted that upon arrival, the patient had an open wound on the left side of their head over the top of their burr hole cap. The patient's healthcare provider (HCP) and a manufacturer representative (rep) were notified of the issue, and the patient was advised to go to the hospital as soon as possible for evaluation. There, they learned there was an infection within the scab. A team of neurosurgeons "removed the scab and took out all the leads that were part of that." (left side system - lead, burr hole cap, and extension were removed on (b)(6) 2026). The patient stated that the rep's decision saved their life. There were no known contributing factors. The issue was resolved.
Patient problems: Scar Tissue; Tissue Breakdown; Unspecified Infection
MAUDE report 50090938 ↗MalfunctionJul 16, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Dysphasia; Electric Shock; Shaking/Tremors
MAUDE report 25847422 ↗MalfunctionJul 14, 2026Battery Problem; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813106 ↗MalfunctionJul 14, 2026Battery Problem; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813093 ↗MalfunctionJul 14, 2026Charging Problem; Connection Problem; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25811128 ↗MalfunctionJul 9, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25759192 ↗MalfunctionJun 11, 2026Charging Problem
IT WAS REPORTED THAT THE RECHARGING ANTENNA THE GRAY CORD IS DAMAGED AND WIRE IS EXPOSED. IT HAS BEEN DAMAGED FOR A LITTLE WHILE. JUST RECENTLY TO THE POINT IN THE PAST 6 MONTHS IT WON'T HOLD A CHARGE THAT LONG. THE RECHARGER WON'T CHARGE PAST A QUARTE OF THE WAY, SO THEY CAN'T FULLY CHARGE THEIR NEUROSTIMULATOR. SENT REQUEST TO REPAIR TO RELACE THE RECHARGE ANTENNA AND THE AC/DTC. 2026-MAY-12 (B)(4) (CON): ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THEY ATTEMPTED TO CHARGE THE RECHARGER BUT THE DEVICE WAS STILL NOT CHARGED AFTER HAVING IT PLUGGED INTO THE WALL. CALLER STATED THAT THE REPLACEMENT DESKTOP CHARGER (DTC) DID NOT RESOLVE THE ISSUE. AGENT SENT MESSAGE TO THE FIELD TO TRANSITION THE PATIENT TO THE WR. 2026-MAY-15 (B)(4) (CON): ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REPLACEMENT DTC AND ANTENNA DID NOT RESOLVE THE ISSUE. THE CALLER STATED THAT THE PATIENT HAS BEEN UNABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR ALMOST A WEEK. CALLER HAS NOT HEARD FROM A MANUFACTURER REP TO TRANSITION THE PATIENT TO THE WR. CALLER MENTIONED THAT THEY SENT A MESSAGE TO THE PATIENT'S HCP A COUPLE OF WEEKS AGO BUT HAVEN'T HEARD BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25468644 ↗MalfunctionJun 8, 2026Overheating of Device; Charging Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED DULL PAIN, BURNING SENSATION, AND A HEATING SENSATION DURING RECHARGING. THE ISSUE WAS R EPORTED TO HAVE STARTED A COUPLE OF MONTHS PRIOR. THERE WERE NO RECENT THERAPY SETTING CHANGES AND NO REPORTED FALL OR TRAUMA. IMPEDANCES WERE CHECKED AND REPORTED AS FINE AND THE PATIENT WAS REPORTED TO BE RECEIVING GOOD SYMPTOM RELIEF. THE PATIENT WAS EVALUATED BY A PHYSICIAN AND THE POCKET SITE WAS NOTED TO LOOK FINE WITH NO PROBLEMS. TROUBLESHOOTING GUIDANCE INCLUDED RECOMMENDING CHARGING WITH CLOTHING OVER THE IMPLANTABLE NEUROSTIMULATOR SITE, PERFORMING MORE FREQUENT BUT SHORTER CHARGING SESSIONS, AND A PLANT TO TRANSITION FROM A LEGACY RECHARGER TO A WIRELESS RECHARGER. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT RECEIVED A WIRELESS RECHARGER BUT THEY COULD NOT GET IT TO PAIR WITH THE HANDSET. THE PATIENT REP HAD ALREADY SPOKEN WITH MANUFACTURER REP, WHO TOLD THE CALLER THAT THE PATIENT MIGHT NEED A NEWER VERSION OF THE HANDSET. AGENT HAD CALLER CHECK HANDSET (J3) AND THE RECHARGER APP WAS NOT INSTALLED. AGENT RE-OPENED CASE AND SENT REQUEST TO THE REPAIR DEPARTMENT TO REPLACE THE HANDSET. ADDITIONAL INFORMATION RECEIVED FROM REP I
Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 25431084 ↗MalfunctionJun 4, 2026Migration or Expulsion of Device; Unintended Collision
IT WAS REPORTED THAT PATIENT FELL AND BROKE THEIR NECK THE OTHER DAY AND IS IN A HOSPITAL AND NEEDS TO DO AN MRI BEFORE THEY CAN DO SURGERY. CALLER SAID THAT THE FOLKS AT THE HOSPITAL ARE CONFUSED ABOUT WHAT TO DO IN TERMS OF GETTING THE PHYSICAL EXAMINATION OF THE DEVICE AND WIRES AND THE BATTERIES BEFORE THEY GO IN THE MRI MACHINE. CALLER ASKED IF THERE IS A LOCAL MANUFACTURER REPRESENTATIVE (REP) THAT CAN DO THE MRI. REVIEWED MRI GUIDELINES AND REDIRECTED CALLER TO PATIENT'S MANAGING HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. WHEN ASKED, CALLER SAID THAT PATIENT'S NEUROLOGIST IS AT THE CLINIC, WHICH IS ABOUT 2 HOURS AWAY FROM THE HOSPITAL AND THE PRIMARY NEUROLOGIST ISN'T ABLE TO INSPECT THE DEVICE HERSELF. CALLER SAID THAT THEY WERE DIRECTED TO CONTACT SOMEONE LOCALLY TO ASSIST. CALLER ALSO SAID THAT THEY JUST GOT BACK FROM AN X-RAY AND THE MRI FACILITY SAID THEY WON'T DO THE SCAN UNLESS SOME VERIFICATION IS PROVIDED. CALLER WANTED TO KNOW ABOUT THE MRI ELIGIBILITY FORM. AFTER CONSULTING WITH TECHNICAL SERVICES AND REVIEWED INFORMATION. EMAIL WAS SENT TO FIELD STAFF TO NOTIFY THEM OF THE SITUATION AND REQUEST THAT THEY FOLLOW UP WITH THE PATIENT REP AND THE HOSPITAL." CA
Patient problems: Bone Fracture(s); Fall; No Clinical Signs, Symptoms or Conditions
MAUDE report 25396355 ↗MalfunctionMay 29, 2026Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) IS LOCATED IN THEIR ABDOMEN AND THAT FOR THE LAST FIVE-SIX MONTHS THEIR INS HAS BEEN MOVING AROUND. THE PATIENT WAS REDIRECTED TO THE HCP TO FURTHER ASSIST WITH THE INS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332893 ↗MalfunctionMay 8, 2026High impedance; Low impedance
IT WAS REPORTED THAT LOW IMPEDANCE/SHORT, 223 OHMS CONTACT 3 ON MONOPOLAR IMPEDANCE ON LEFT CONTACT. PATIENT (PT) REPORTING NO LOSS OF THERAPY OR CHANGE IN RECHARGE RESPONSIBILITY. HIGH IMPEDANCE, 2025 OHMS, CONTACT 8 ON MONOPOLAR IMPEDANCE RIGHT CONTACT. PT REPORTING NO LOSS OF THERAPY OR CHANGE IN RECHARGE RESPONSIBILITY. PT REPORTED HAVING A FALL IN 2024 AS A POTENTIAL CONTRIBUTING FACTOR. IMPEDANCES RECHECKED ON AUTO AND VARIOUS AMPLITUDES. PT TO RETURN TO CLINIC IN 3 MOS FOR INTERROGATION. MANUFACTURER REPRESENTATIVE (REP) INDICATES THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128581 ↗MalfunctionMay 6, 2026Improper or Incorrect Procedure or Method; Battery Problem
2026-MAY-05 RTG1041741 (REP): IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE STATING THE PATIENT RESIDED IN A NURSING FACILITY WHERE STAFF HAD REPORTEDLY REFUSED TO CHARGE THE IMPLANTED NEUROSTIMULATOR. THE REPRESENTATIVE INITIALLY BELIEVED THE BATTERY WAS DEPLETED BUT LATER REPORTED THAT THE DEVICE HAD ENTERED AN OVERDISCHARGE STATE. THE REPRESENTATIVE ALSO REPORTED OBSERVING A MESSAGE INDICATING THE RECHARGER WAS MISSING THE TARGET. ATTEMPTS TO CONNECT USING THE PATIENT PROGRAMMER AND A CLINICIAN TABLET WERE UNSUCCESSFUL. TECHNICAL SERVICES REVIEWED INSTRUCTIONS FOR INITIATING PHYSICIAN RECHARGE MODE. 2026-MAY-07 E1 (REP): THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE OVERDISCHARGE CONDITION WAS ADDRESSED BY FOLLOWING THE OVERDISCHARGE RECOVERY PROCEDURE AND CHARGING THE BATTERY TO 50%. STAFF AT THE REHABILITATION FACILITY WERE ALSO INSTRUCTED ON PROPER CHARGING PROCEDURES. THE PATIENT EXPERIENCED STIFFNESS ASSOCIATED WITH THE OVERDISCHARGE. THE DATE THE CONDITION WAS FIRST OBSERVED BY THE PHYSICIAN IS UNKNOWN. THE INFORMATION WAS CONFIRMED AND PROVIDED BY THE PHYSICIAN.
Patient problems: Insufficient Information; Muscular Rigidity
MAUDE report 25107379 ↗MalfunctionMay 6, 2026Failure to Deliver Energy
IT WAS REPORTED THAT PATIENT (PT) THINKS THEY MIGHT HAVE DONE SOMETHING WRONG WITH THE CONTROLLER OR SOMETHING HAPPENED BECAUSE THEY WERE TRYING TO CHANGE THE SETTINGS ON THE CONTROLLER, BUT THEY MIGHT HAVE PRESSED SOMETHING ELSE. AGENT WALKED PATIENT THROUGH CONNECTING TO THEIR IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT STATED THEY WERE SEEING A FLASHING OFF SIGN ON THE PROGRAMMER. AGENT ASKED IF THEY WANTED THEIR THERAPY ON. PATIENT SAID YES, SO AGENT WALKED PATIENT THROUGH TURNING THEIR THERAPY ON AND PATIENT WAS ABLE TO TURN THEIR THERAPY ON. EITHER WAY, AGENT FLAGGED CASE AS STAGING RECORD TO BE CONSERVATIVE. DUE TO NATURE OF CALL AND PATIENT HAVING A HARD TIME FOLLOWING DIRECTIONS ON HOW TO FIND SERIAL NUMBERS, SERIAL NUMBERS OF EXTERNAL DEVICES AND EVENT DATE WERE NOT GATHERED DURING THE CALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096952 ↗MalfunctionApr 21, 2026Delayed Charge Time
ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE PATIENT CALLED BACK, REITERATING PRIOR CONCERNS, AND ADDED THAT WHILE HOLDING THE RECHARGER, THE ANTENNA WAS MIGRATING AWAY FROM THE INS, MAKING CHARGING DIFFICULT. THE CALLER REPORTED DIFFICULTY SEEING SYMBOLS AND BUTTONS ON THE PROGRAMMER AND RECHARGER, AND STATED THAT AFTER HOLDING THE ANTENNA OVER THE INS FOR APPROXIMATELY ONE HOUR, THE BATTERY LEVEL REMAINED AT 50%, UNCHANGED FROM THE START OF CHARGING. THE CALLER ALSO NOTED NOT RECEIVING AN UPDATE AFTER ONE WEEK REGARDING THE WIRELESS RECHARGER THAT WAS EXPECTED TO BE SENT. THE AGENT REVIEWED THE TRANSITION PROCESS FROM THE CURRENT RECHARGER TO THE WIRELESS RECHARGER AND SENT AN EMAIL TO THE FIELD TEAM FOR VISIBILITY AND FOLLOW-UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940020 ↗MalfunctionApr 21, 2026Charging Problem; Connection Problem
IT WAS REPORTED THAT THE WIRELESS RECHARGER (ACTIVA RC) FOR A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) WAS UNRESPONSIVE, THE DOCK WAS NOT STAYING LIT, AND THE RECHARGER WAS NOT CHARGING FROM THE DOCK. THE GREEN LIGHT ON THE DOCK WOULD NOT COME ON UNLESS THE CORD WAS POSITIONED IN A CERTAIN WAY, AND THE GREEN LIGHTS ON THE RECHARGER WERE OBSERVED TO SCROLL RAPIDLY. THERE WAS A POSSIBLE CONNECTIONISSUE WITH THE CORD AND DOCK. THERE WAS CONCERN FOR THE IMPLANTABLE NEUROSTIMULATOR BATTERY DEPLETING, AS THE PATIENT WAS AT 50% CHARGE. THE PATIENT REPRESENTATIVE UNPLUGGED THE AC POWER SUPPLY AND PLUGGED IT INTO A DIFFERENT OUTLET, BUT THE SAME ISSUE OCCURRED. PATIENT SERVICES REVIEWED BEST PRACTICES FOR RECHARGING WITH THE CALLER AND ADVISED TO KEEP THE DOCK PLUGGED IN AND THE RECHARGER ON THE DOCK WHEN NOT IN USE. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DOCK, RECHARGER, CHARGING CABLE, AND WALL ADAPTOR DUE TO THE URGENCY OF CHARGING THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939354 ↗MalfunctionApr 17, 2026Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem
IT WAS REPORTED THAT THE PATIENT WOULD TYPICALLY CHARGE THEIR IMPLANTED NEUROSTIMULATOR FOR ABOUT 90 MINUTES AND TODAY (ON (B)(6) 2026, AND LAST WEEK TOO) THEY PUT THE RECHARGER ON THE PATIENT AND IT WENT FOR LIKE 25 MINUTES AND THEN IT STARTED BEEPING AGAIN. THE CALLER STATED THEY WOULD HAVE TO REPOSITION THE RECHARGING ANTENNA TO GET THE SENSORS MATCHED UP ON THE SENSOR UNDER THE PATIENT'S SKIN AND IT WOULD WORK FOR LIKE A MINUTE AND THEN THE BEEPING WOULD START AGAIN. CALLER CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHIFTING UNDER THE PATIENT'S SKIN. PATIENT WAS IN THE BACKGROUND OF THE CALL AND SAID THE INS HAD BEEN MOVING AROUND FOR A LONG TIME AND THAT THE MOVING AROUND HAD STARTED BEFORE THE RECENT ISSUE WITH THE RECHARGER NOT STAYING CONNECTED HAD BEGUN. CALLER SAID THE RECHARGER NOT CONNECTING APPEARED TO HAVE HAPPENED ALL OF SUDDEN AND THEY NEVER HAD AN ISSUE BEFORE. THEY ALSO MENTIONED THEY WERE NOT WITH THE PATIENT EVERY DAY SO THEY WOULD ASK THE OTHER CAREGIVERS IF THEY'D NOTICED AN ISSUE. PATIENT COULD NOT SAY FOR HOW LONG THE INS HAD BEEN MOVING AROUND. PATIENT SERVICES REVIEWED RECHARGING CONSIDERATIONS WITH THE CALLER. THE CALLER SAID THE PATIENT WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911659 ↗MalfunctionApr 17, 2026Connection Problem; Material Integrity Problem
IT WAS REPORTED THAT THEY HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A MESSAGE WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. AGENT ASKED WHEN THEY NOTICED THE DEVICE DAMAGED AND THEY SAID MAYBE LAST WEEK. PATIENT WAS ABLE TO GET THE BROKEN METAL PIN OUT OF THE RECHARGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908117 ↗MalfunctionApr 14, 2026Connection Problem; Material Integrity Problem
IT WAS REPORTED THAT THE METAL TIP OF THE ADAPTER DETACHED. THE ADAPTER WAS REPLACED, AND THE ISSUE WAS REPORTED AS RESOLVED. 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 24874514 ↗
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, ClassifiedMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Z-2241-2026 · May 13, 2026 · Open, ClassifiedMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- Z-0206-2025 · Sep 24, 2024 · Open, ClassifiedMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
- Z-0372-2025 · Sep 18, 2024 · Open, ClassifiedMedtronic 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 · CompletedLEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Z-1128-2022 · Mar 30, 2022 · Open, ClassifiedPercept BrainSense Implantable Neurostimulator (INS), Model B35200
- Z-0418-2022 · Oct 19, 2021 · Open, ClassifiedModel B35200 - Percept PC BrainSense Implantable Neurostimulator
- Z-0201-2022 · Sep 23, 2021 · Open, ClassifiedClinician Programmer Application (CPA) model A610 Clinician Software Application
- Z-1368-2021 · Mar 9, 2021 · Open, ClassifiedA610 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 · TerminatedDBS 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 · TerminatedDBS 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 · TerminatedMedtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
- Z-1617-2015 · Apr 16, 2015 · TerminatedMedtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Z-0279-2014 · Sep 30, 2013 · TerminatedMedtronic 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 · TerminatedMedtronic 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.
Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR devices
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Infinity™ 6662St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- Activa® SC 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death443 reports
- Infinity™ 7St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor2 deaths371 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall10 deaths306 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.