Activa® SC 37602 (UDI 00643169864207)Recalls & reported problems
Medtronic, Inc. · INS 37602 ACTIVA SC NO PARYLN EMN DBSALP · Class f · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Activa SC stimulator has 229 adverse event reports, including 139 malfunctions, 89 injuries and 1 death. The reports mostly describe battery and electrical problems, with some describing shaking, electric shocks and pain. 1 recall names this device. It is open and began in May 2024; it limits MRI scans to the head only for patients with certain pocket adaptors.
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
- 228
- Deaths reported
- 1
- Injuries reported
- 88
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 00643169864207), received between May 7, 2018 and Jul 8, 2026 — classified as 1 death, 88 injuries, 139 malfunctions.
The most frequently reported specific device problem is “High impedance” (43 reports).
1 FDA recall record name this device's identifier, 1 still open.
20 other recalls cover devices cleared under the same FDA submission (H020007, 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
Recalls naming this device
- May 15, 2024Open, Classified
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Z-2427-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- High impedance43
- Adverse Event Without Identified Device or Use Problem42
- Insufficient Device Problem Information29
- Battery Problem27
- Low impedance26
- Energy Output Problem19
- Premature Discharge of Battery17
- Inappropriate/Inadequate Shock/Stimulation16
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Known Impact Or Consequence To Patient51
- Shaking/Tremors29
- Insufficient Information22
- Electric Shock17
- Unspecified Infection17
- Complaint, Ill-Defined14
- Pain12
Recent adverse event reports
The 25 most recent of 228 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD THE BATTERIES REPLACED LAST WEEK BECAUSE IT WAS PROBABLY OVERDUE. PATIENT HAD BEEN HAVING PHYSICAL DISCOMFORT SO THEY GOT THE BATTERY REPLACED.
Patient problems: Discomfort
MAUDE report 25752729 ↗MalfunctionJan 5, 2026High impedance
IT WAS REPORTED THAT PATIENT HAD KNOWN ELEVATED IMPEDANCE ON L IMPLANTABLE NEUROSTIMULATOR (INS) CONTACT 0. THIS CONTACT IS NOT BEING USED FOR THERAPY. REPLACED IMPLANTABLE NEUROSTIMULATOR (INS) AND IMPEDANCE REMAINED WITH NO FURTHER ACTION REQUESTED BY PHYSICIAN OR COMPLAINTS FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957487 ↗MalfunctionJan 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED DEEP BRAIN STIMULATION WAS TURNED OFF A LONG TIME AGO BECAUSE THE WIRES WEREN¿T WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079990 ↗InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS GOTTEN VERY GOOD RELIEF SINCE A COUPLE MONTHS AGO. PATIENT MOVED TO CALIFORNIA IN 2010 AND HEALTHCARE PROVIDER (HCP) STARTED TO MAKE THERAPY ADJUSTMENTS, WHICH CAUSED THINGS TO GO "SOUTH". PATIENT SAID SHE WAS IN PAIN TO THE POINT THAT SHE CONSIDERED CUTTING THE NERVE, SHE GOT 400 UNITS OF BOTOX, THEN SHE GOT THE MORPHINE PUMP AND PAIN MEDICATION AND IT STILL DIDN'T HELP. PATIENT SAID HER MUSCLE WAS TOO EXTENDED THAT THEY WERE STICKING OUT. PATIENT SAID THE PAIN WAS SO MUCH THAT IT CAUSED HER TO CLENCH HER TEETH TO THE POINT THAT HER TEETH CRACKED. PATIENT FELT THAT HER DOCTORS COULD HAVE DONE BETTER TO GET HER SETTINGS FROM PER PHYSICIAN BACK IN THE EAST COAST, RATHER THAN MAKING ALL THE ADJUSTMENTS THAT CAUSED ALL HER MEDICAL ISSUE. PATIENT SAID MDT REP WAS ABLE TO CREATE 2 GROUPS, ONE TO ALLOW VOLTAGE CHANGES AND ANOTHER GROUP THAT ALLOWED PULSE WIDTH CHANGE. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THEY HAVE AXIAL TRUNCAL DYSTONIA, WHICH MEANS THE MUSCLES THAT SURROUND THEIR SPINE ARE ATTACHED TO THEIR VERTEBRAE AND ARE YANKING AT EACH OTHER AND IT'S SUPER PAINFUL AND IT GIVES THEM SCOLIOSIS WHICH RESULTS IN SOFT TISS
Patient problems: Abscess; Cramp(s) /Muscle Spasm(s); Insufficient Information; Muscular Rigidity; Pain; Unspecified Nervous System Problem
MAUDE report 20281195 ↗InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS GOTTEN VERY GOOD RELIEF SINCE A COUPLE MONTHS AGO. PATIENT MOVED TO (B)(6) IN 2010 AND HEALTHCARE PROVIDER (HCP) STARTED TO MAKE THERAPY ADJUSTMENTS, WHICH CAUSED THINGS TO GO "SOUTH". PATIENT SAID SHE WAS IN PAIN TO THE POINT THAT SHE CONSIDERED CUTTING THE NERVE, SHE GOT 400 UNITS OF BOTOX, THEN SHE GOT THE MORPHINE PUMP AND PAIN MEDICATION AND IT STILL DIDN'T HELP. PATIENT SAID HER MUSCLE WAS TOO EXTENDED THAT THEY WERE STICKING OUT. PATIENT SAID THE PAIN WAS SO MUCH THAT IT CAUSED HER TO CLENCH HER TEETH TO THE POINT THAT HER TEETH CRACKED. PATIENT FELT THAT HER DOCTORS COULD HAVE DONE BETTER TO GET HER SETTINGS FROM PER PHYSICIAN BACK IN THE (B)(6), RATHER THAN MAKING ALL THE ADJUSTMENTS THAT CAUSED ALL HER MEDICAL ISSUE. PATIENT SAID MDT REP WAS ABLE TO CREATE 2 GROUPS, ONE TO ALLOW VOLTAGE CHANGES AND ANOTHER GROUP THAT ALLOWED PULSE WIDTH CHANGE. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THEY HAVE AXIAL TRUNCAL DYSTONIA, WHICH MEANS THE MUSCLES THAT SURROUND THEIR SPINE ARE ATTACHED TO THEIR VERTEBRAE AND ARE YANKING AT EACH OTHER AND IT'S SUPER PAINFUL AND IT GIVES THEM SCOLIOSIS WHICH RESULTS IN SOFT TISSUE PAIN.
Patient problems: Abscess; Cramp(s) /Muscle Spasm(s); Insufficient Information; Muscular Rigidity; Pain; Unspecified Nervous System Problem
MAUDE report 20281113 ↗MalfunctionAug 28, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WENT TO CHECK THEIR STIMULATORS TODAY USING THEIR PATIENT PROGRAMMER, AND THEY COULD CONNECT WITH THE ONE ON THEIR RIGHT SIDE, BUT THEY KEPT GETTING ERROR MESSAGES ON THE LEFT. THE AGENT WORKED WITH THE PATIENT TO SYNCH WITH THEIR LEFT STIMULATOR, AND AFTER REPOSITIONING TO RESOLVE POOR COMMUNICATION, THE PATIENT WAS SUCCESSFUL IN CONNECTING. AFTER POWERING THE PROGRAMMER DOWN AND BACK UP, THE PATIENT REPORTED SEEING ERI. THEY NAVIGATED TO THEIR ON/OK SETTING AND THEN CHECKED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD 2.58V LEFT. THE AGENT REVIEWED ERI/ EOS INFORMATION AND REDIRECTED THE PATIENT TO SPEAK WITH THEIR DOCTOR ABOUT ELECTIVE REPLACEMENT INTERVALS. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP CONFIRMING THAT ERI WAS NORMAL. IT WAS RESOLVED ONCE THE BATTERY WAS REPLACED. A USE BEFORE DATE (UBD) ISSUE WAS IDENTIFIED. THE IMPLANT DATE IS GREATER THAN UBD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20087036 ↗MalfunctionJul 22, 2024Failure to Power Up; Failure to Power Up
INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED STARTING TWO WEEKS AGO THE PATIENT PROGRAMMER (PP) WOULDN¿T POWER ON EVEN AFTER THEY PUT IN BRAND NEW ALKALINE BATTERIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801408 ↗InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED PATIENT PRESENTED TO THE EMERGENCY ROOM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) HANGING FROM THEIR CHEST. THE ENTIRE LEFT SIDE SYSTEM WAS REMOVED ON (B)(6) 2024. FROM THE "CONDITION OF THE WOUND" IT HAS BEEN GOING ON "A WHILE". THE PATIENT IS CURRENTLY UNDER THE CARE OF PLASTICS AS THEY PLAN TO REPAIR EVERYTHING.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 19750015 ↗MalfunctionMay 1, 2024High impedance; High impedance
IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) WENT TO SEE PATIENT IN PRE OP BEFORE HIS BATTERY REPLACEMENT TO TRANSFER HIS SETTINGS TO A NEW BATTERY. REP RAN AN IMPEDANCE TEST AND GOT HIGH IMPEDANCES ON CONTACT 2. REP NOTIFIED THE SURGEON OF THE IMPEDANCE ISSUE, HOWEVER AFTER CONNECTING THE NEW BATTERY TO THE EXTENSIONS IN THE OR, THERE WAS NO LONGER AN IMPEDANCE ISSUE. ALL RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF HIGH IMPEDANCES WAS NOT DETERMINED. THEY RESOLVED ONCE WE PLACED THE NEW BATTERY IN SO NO FURTHER INVESTIGATING WAS DONE. THE IMPEDANCES ARE NOW ALL CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220645 ↗MalfunctionFeb 23, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE PATIENT HAD A DAMAGED DESKTOP CHARGER (DTC) CORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18768811 ↗MalfunctionFeb 2, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT LAST WEEK THE PATIENT WENT IN FOR A EKG AND THEY WERE UNBALE TO TURN OFF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER DUE TO THE PATIENT PROGRAMMER NOT POWERING ON. THE CALLER CONFIRMED THAT THEY WERE NEW BATTERIES AND PSS HAD THE CALLER TAKE THE BATTERIES IN/OUT TO ENSURE THAT THEY WERE IN THE PATIENT PROGRAMMER CORRECTLY. THE CALLER PRESSED THE POWER BUTTON ON THE PATIENT PROGRAMMER AND THE STATED THAT THE SCREEN WAS BLANK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632202 ↗MalfunctionFeb 2, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT PROGRAMMER WON'T POWER ON WITH NEW AAA BATTERIES. NO SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629664 ↗MalfunctionFeb 1, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem
IT WAS REPORTED THAT THE REASON FOR CALL WAS CALLER REPORTED THAT LAST MONTH, THEY HAD TRIED TO USE THE PATIENT PROGRAMMER AND NOTICED IT WASN'T POWERING ON. THE CALLER STATED AT THAT TIME, THEY WERE NOT ABLE TO ACCESS THE BATTERY COMPARTMENT, AND DID NOT LOOK INTO IT AS THE PATIENT HADN'T NEEDED TO USE THE PATIENT PROGRAMMER UNTIL NOW. DURING THE CALL, PATIENT SERVICES (PSS) REVIEWED HOW TO OPEN BATTERY COMPARTMENT. CALLER STATED THEY HAD TO USE STRENGTH, AND THEY HAD REALIZED THAT THE REASON THE BATTERY COMPARTMENT WAS NOT EASILY ACCESSIBLE OR NOTICEABLE WAS BECAUSE A STICKER WAS PUT ON THE BACK, OVER THE COMPARTMENT. THE CALLER WAS ABLE TO ACCESS THE BATTERY COMPARTMENT. THE CALLER TRIED A SET OF AAA BATTERIES THEY HAD IN THEIR HOME, AND THE PATIENT PROGRAMMER DID NOT TURN ON. THE CALLER INFORMED PSS THAT THEY SAW A LITTLE BIT OF CORROSION IN THE BATTERY COMPARTMENT. THE CALLER STATED THEY WERE NOT SURE HOW OLD OR IF THE BATTERIES HAD BEEN USED, AND STATED THEY WANTED TO GO OUT AND BUY NEW BATTERIES TO TRY. THE ISSUE WAS NOT RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18621370 ↗MalfunctionJan 30, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem
IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULDN'T POWER ON WITH NEW BATTERIES. PATIENT (PT) TOOK BATTERIES OUT OF PATIENT PROGRAMMER TO ENSURE THEY WERE INSERTED THE RIGHT WAY BUT THIS DIDN'T RESOLVE ISSUE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED PT SAID THAT THEIR HANDS TREMOR A LOT FROM AN EARLY ACCIDENT. PT SAID THAT THEIR LEFT HAND WAS TREMORING SO MUCH THAT THEY HAD TO SWITCH TO USING THEIR RIGHT HAND. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE "EARLY ACCIDENT" WAS THE DBS WAS ABOUT 5 YEARS TOO OLD. ON (B)(6) 2023 THE PATIENT SAW THEIR NEUROLOGIST AND HEALTHCARE PROVIDER (HCP) WHO TOLD THE PATIENT THAT THEIR INTERNAL DEVICE HAD INTERNAL BATTERIES TOO LOW. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE "DBS WAS ABOUT 5 YEARS OLD" WAS NOT A DBS DEVICE, THERAPY OR PROCEDURE ISSUE AND WAS NOT REFERRING TO THE IMPLANT BEING LOW/AT ERI. NO FURTHER INFORMATION WAS GIVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Shaking/Tremors
MAUDE report 18611196 ↗MalfunctionJan 29, 2024Failure to Power Up; Failure to Power Up
INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE PROGRAMMER WOULDN¿T POWER UP EVEN AFTER A NEW BATTERY WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18602043 ↗MalfunctionJan 29, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULDN'T POWER ON AFTER TRYING NEW BATTERIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18601691 ↗MalfunctionJan 24, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) WOULD NOT POWER ON. THE ISSUE PERSISTED AFTER REPLACING THE BATTERIES IN THE PP AND THEY CONFIRMED THEY USED BRAND NEW, REGULAR ALKALINE BATTERIES. THEY HAVE NOTIFIED THEIR NEUROLOGIST REGARDING THIS ISSUE. NO PATIENT SYMPTOMS WERE REPORTED. A REPLACEMENT PP WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576731 ↗MalfunctionJan 24, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) WOULD NOT POWER ON. THE ISSUE PERSISTED AFTER REPLACING THE BATTERIES IN THE PP AND THEY CONFIRMED THEY USED BRAND NEW, REGULAR ALKALINE BATTERIES. THEY HAVE NOTIFIED THEIR NEUROLOGIST REGARDING THIS ISSUE. NO PATIENT SYMPTOMS WERE REPORTED. A REPLACEMENT PP WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576724 ↗MalfunctionNov 15, 2023Failure to Power Up; Operating System Becomes Nonfunctional; Failure to Power Up; Operating System Becomes Nonfunctional
INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE PATIENT PROGRAMMER RECENTLY STOPPED WORKING. IT WAS CONFIRMED THE CONSUMER WAS USING REGULAR ALKALINE BATTERIES. THE BATTERIES WERE TAKEN OUT AND THEY TRIED TO POWER THE DEVICE ON, BUT NOTHING HAPPENED, AND IT WAS UNRESPONSIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18139992 ↗MalfunctionNov 9, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DESKTOP CHARGER (DTC) HAD A BROKEN CONNECTOR PIN. NO SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18106149 ↗MalfunctionOct 20, 2023Failure to Deliver Energy; Energy Output Problem; Failure to Deliver Energy; Energy Output Problem
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THERAPY BEING OFF WAS THE DEVICE OR DEVICES NOT WORKING TOO WELL. THE ISSUE HAD ¿NOT QUITE¿ BEEN RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17979972 ↗MalfunctionSep 18, 2023High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED IT WAS UNKNOWN IF THE JOLTING WAS RESOLVED AS THE PHYSICIAN HADN¿T SEEN THE PATIENT SINCE SURGERY.
Patient problems: Electric Shock
MAUDE report 17765940 ↗InjuryAug 15, 2023Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem
MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT. FURTHER REVIEW INDICATED THE EVENT WAS REPORTED IN ERROR. THERE WERE NO ALLEGATIONS OF ABNORMAL BATTERY DEPLETION OR THE DEPLETION WAS PREMATURE.
Patient problems: Ambulation or Postural Difficulties; Bruise/Contusion; Fall
MAUDE report 17548477 ↗InjuryApr 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD SOME ISSUES WITH THEIR PRIOR STIMULATOR AND THAT IS WHY THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED. NO SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806974 ↗MalfunctionApr 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THERE WAS NOTHING WRONG WITH THE WIRING OF THE DBS, THE HEALTHCARE PROVIDER (HCP) JUST WANTED TO CHECK IT BUT DIDN¿T SUSPECT ANYTHING WAS WRONG WITH THE LEAD PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16804416 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under H020007, P960009. One submission often covers many models, so check the product and lot details in each record.
- 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-2240-2026 · May 13, 2026 · Open, ClassifiedMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; 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 implanted subcortical electrical Stimulator (motor disorders) devices
- ACTIVA PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)15 deaths1,625 reports
- Activa® PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 death502 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)3 recalls1 death280 reports
- Activa® SC 37602Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 recall59 reports
- DBS™ 3389S-40Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)99 reports
- SenSight™ B31061Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 recall20 reports
- N/A 64002Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 recall1 report
- DBS 3387S-40Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 death24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.