Activa® SC 37603 (UDI 00763000519230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00763000519230), received between May 9, 2022 and Sep 8, 2026 — classified as 48 injuries, 63 malfunctions.

The most frequently reported specific device problem is “High impedance” (21 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, H050003, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Electromagnetic Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677935 ↗
• MalfunctionSep 8, 2026Electromagnetic Compatibility Problem

  Additional information received from manufacturer representative (rep), cause of artifacts remains unknown but it is suspected that the multiple devices are contributing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677905 ↗
• InjuryJul 30, 2026High impedance; Impedance Problem

  It was reported that patient had some impedance issue showing as investigate that would not clear, so the neurosurgeon decided to replace the lead, extension, and battery. No known cause or contributors to this issue. Issue is considered resolved on replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083875 ↗
• InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation

  The manufacturer representative provided additional information indicating that the cause of the shocking sensation was not determined and no contributing factors were identified. The physician switched the settings to mA, but no other corrective steps are known at this time. Resolution status is unknown because the patient has not yet responded to follow-up. The information was confirmed by the physician.

  Patient problems: Electric Shock

  MAUDE report 50083758 ↗
• MalfunctionJul 8, 2026Break; Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall

  MAUDE report 25748503 ↗
• MalfunctionJul 8, 2026Break

  Patient problems: Fall

  MAUDE report 25748458 ↗
• MalfunctionMay 5, 2026Battery Problem

  IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS INTERROGATED IN ORDER TO ACTIVATE IT PRIOR TO USE AND THE IMPLANT WAS NOTED TO BE DISCHARGED MORE THAN WAS EXPECTED OR NORMAL WHILE SITTING IDLE. THERE WERE NO PATIENT FACTORS ASSOCIATED WITH THIS EVENT AS THIS DEVICE WAS NEVER IMPLANTED. IT IS STILL IN THE ORIGINAL MANUFACTURER PACKAGING. NO ACTIONS WERE TAKEN AND THE ISSUE IS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087328 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REMOVAL OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE REASON FOR DEVICE REMOVAL IS UNKNOWN. INFORMATION HAS BEEN CONFIRMED BY HEALTHCARE PROVIDER (HCP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899171 ↗
• InjuryMar 12, 2026Break; High impedance; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT BATTERY AT 2.59V AND ERI ALERT DID NOT SHOW UP. PATIENT IS BEING REFERRED FOR REPLACEMENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE INDICATING HIGH IMPEDANCE AT CONTACT 3 ON BOTH HEMISPHERES: ON THE LEFT GPI, CONTACT 3 MONOPOLAR MEASURED 2293 OHMS; ON THE RIGHT GPI, ALL CONFIGURATIONS INVOLVING CONTACT 3 (MONOPOLAR AND BIPOLAR) WERE OUT OF RANGE; NEITHER OF THESE CONTACTS IS CURRENTLY USED IN THE PATIENT¿S PROGRAMMING CONFIGURATION. THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT PER CLINICIAN, THE IMPLANTABLE NEUROSTIMULATOR REACHED THE ERI STATUS DUE TO NORMAL BATTERY DEPLETION. FULL NARRATIVE PROVIDED BY REP: PATIENT HAD BILATERAL BATTERY REPLACEMENT AND BILATERAL EXTENSION REVISION DONE 3/3/2026. IT WAS OB SERVED THAT THE PATIENT HAD METAL DOG BONES OVER THE EXTENSION LEAD CONNECTION POINTS. ADDITIONALLY, THERE WERE NO SUTURES OVER THE LEGACY BOOTS. THIS WAS DONE OUTSIDE THE US. THE CLINICIAN FELT THIS COULD LIKELY HAVE CONTRIBUTED TO THE IMPEDANCE ISSUE, SINCE WHEN HE REMOVED THE METAL DOG BONES BOTH EXTENSIONS WERE KINKED/DENTED FROM THE METAL. LEFT LEAD AND EXTENSION OBSERVATIONS: WHEN THE LEF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582397 ↗
• MalfunctionMar 9, 2026High impedance

  IT WAS REPORTED THAT DURING A ROUTINE BATTERY CHANGE, IMPEDANCE TESTING DETECTED HIGH IMPEDANCE (>25K) FOR CONTACT 0 MONOPOLAR AND ALL BIPOLAR PAIRS. IMPEDANCE DID NOT RESOLVE THE IMPEDANCE OUT OF RANGE FOR CONTACT 0. THIS CONTACT IS NOT USED IN PROGRAMMING FOR THE PATIENT'S THERAPY MANAGEMENT THUS NO FURTHER ACTION WAS TAKEN NOR IS PLANNED AT THIS TIME.  CAUSE WAS NOT KNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545247 ↗
• InjuryMar 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE HOSPITAL WITH RECENT FALLS. CALLER REPORTED IN THE PAST COUPLE OF DAYS THE PATIENT HAD MULTIPLE FALLS AND THE ADMITTING PHYSICIANS BELIEVES PATIENT'S DBS MAYBE MALFUNCTIONING. AT THE TIME OF THE CALL, THE SYSTEM COULD NOT BE INTERROGATED FOR TROUBLESHOOTING AS THE INITIAL REPORTER WAS NOT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AT A LATER DATED THAT PATIENT REQUESTED ASSISTANCE CHECKING THEIR IMPLANT STATUS. AGENT WALKED PATIENT THROUGH CONNECTING TO EACH IMPLANT AND PATIENT REPORTED THAT THERAPY WAS ON FOR BOTH IMPLANTS. PATIENT HAS AN UPCOMING APPOINTMENT WITH A PROVIDER.

  Patient problems: Fall

  MAUDE report 24500454 ↗
• MalfunctionFeb 25, 2026Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT  PATIENT WENT TO SEE THE NEUROLOGIST LAST WEEK FOR A CHECK-UP AND THE NEUROLOGIST DIDN'T HAVE THE TOOLS TO CHECK THE BATTERY. CALLER SAID THAT THEY CHECKED THE BATTERY TODAY AND SAW A YELLOW LIGHT WHICH SAID NEEDS ATTENTION. REVIEWED EXTERNAL DEVICES. WITH INSTRUCTION, CALLER CONNECTED TO IMPLANT AND RECEIVED ERI (ELECTIVE REPLACEMENT INTERVAL) MESSAGE. REVIEWED MEANING OF THE MESSAGE. CALLER SAID THAT WAS TOLD THAT THE IMPLANT SHOULD LIKE 3-5 YEARS, SAID THAT NONE OF THEM HAVE LASTED THAT LONG. REVIEWED THAT LONGEVITY IS AFFECTED BY THE SETTINGS USED BY THE PATIENT, WHICH VARIES FOR EACH PATIENT. THE CALLER WAS REDIRECTED TO CONTACT PATIENT'S HEALTHCARE PROVIDER TO NOTIFY THEM REGARDING THE ERI MESSAGE AND TO DISCUSS REPLACEMENT OPTIONS REVIEWED DEVICE INFORMATION. CALLER ALSO MENTIONED THAT PATIENT HAS DEMENTIA AND DOESN'T KNOW IF PATIENT CAN HANDLE THE RECHARGEABLE SYSTEM. CALLER PROVIDED NEW ADDRESS AND PHONE NUMBER AND FOLLOW UP PHYSICIAN. EMAIL WAS SENT TO PATIENT REGISTRATION TO UPDATE PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444952 ↗
• InjuryFeb 23, 2026Break; High impedance; Battery Problem; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BATTERY WAS AT 2.59V, AND THE ERI ALERT DID NOT APPEAR. PATIENT IS BEING REFERRED FOR REPLACEMENT. ON 2026-FEB-10 FU_MPXR 1388681 (HCP, REP): ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE ON FEBRUARY 10TH INDICATING HIGH IMPEDANCE AT CONTACT 3 ON BOTH HEMISPHERES: ON THE LEFT GPI, CONTACT 3 MONOPOLAR MEASURED 2293 OHMS; ON THE RIGHT GPI, ALL CONFIGURATIONS INVOLVING CONTACT 3 (MONOPOLAR AND BIPOLAR) WERE OUT OF RANGE; NEITHER OF THESE CONTACTS IS CURRENTLY USED IN THE PATIENT¿S PROGRAMMING CONFIGURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423696 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SAID HIS BARBER NOTICED AN EXPOSED WIRE. SINCE DBS IS HIS ONLY IMPLANT, IT IS ALMOST CERTAINLY A DBS LEAD WIRE. PATIENT'S NEUROLOGIST IS BRINGING HIM IN TODAY TO EXAMINE THE AREA, CHECK FOR INFECTION, AND REFER TO THE PATIENT'S IMPLANTING NEUROSURGEON IF NEEDED. ISSUE IS UNRESOLVED AT TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THE LEAD/EXTENSION JUNCTION SITE IS EXPOSED. MRI ELIGIBILITY FORM HAS BEEN FILLED OUT AND IMPEDANCE ARE WITHIN NORMAL LIMITS. CALLER REPORTS PATIENT IS SCHEDULED FOR MRI; NEUROSURGEON WILL BE EXPLANTING THE ENTIRE SYSTEM AND RE-IMPLANT LATER. CALLER REPORTS PATIENT HAS FINISHED WITH THE MRI SCAN, 15 MINUTES POST SCAN. CALLER REPORTS PATIENT HAD NO ISSUE OR COMPLAINTS. IMPEDANCE RE-CHECK AND WAS NORMAL. CALLER REPORTS PATIENT TURNED STIMULATION BACK ON. PATIENT HAS FOLLOW UP APPOINTMENT WITH PHYSICIAN, WILL BE MEETING WITH PLASTIC SURGEON SINCE PATIENT HAD LEAD/EXTENSION EXPOSED. PATIENT ALSO INDICATED ALL COMPONENTS WILL BE EXPLANTED, LET THE SITE HEAL FOR PERIOD OF TIME, AFTER THE HEALING PROCESS, PATIENT WILL THEN HAVE THE SYSTEM RE-IMPLANT.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388895 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SAID HIS BARBER NOTICED AN EXPOSED WIRE. SINCE DBS IS HIS ONLY IMPLANT, IT IS ALMOST CERTAINLY A DBS LEAD WIRE. PATIENT'S NEUROLOGIST IS BRINGING HIM IN TODAY TO EXAMINE THE AREA, CHECK FOR INFECTION, AND REFER TO THE PATIENT'S IMPLANTING NEUROSURGEON IF NEEDED. ISSUE IS UNRESOLVED AT TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THE LEAD/EXTENSION JUNCTION SITE IS EXPOSED. MRI ELIGIBILITY FORM HAS BEEN FILLED OUT AND IMPEDANCE ARE WITHIN NORMAL LIMITS. CALLER REPORTS PATIENT IS SCHEDULED FOR MRI, NEUROSURGEON WILL BE EXPLANTING THE ENTIRE SYSTEM AND RE-IMPLANT LATER. CALLER REPORTS PATIENT HAS FINISHED WITH THE MRI SCAN, 15 MINUTES POST SCAN. CALLER REPORTS PATIENT HAD NO ISSUE OR COMPLAINTS. IMPEDANCE RE-CHECK AND WAS NORMAL. CALLER REPORTS PATIENT TURNED STIMULATION BACK ON. PATIENT HAS FOLLOW UP APPOINTMENT WITH PHYSICIAN, WILL BE MEETING WITH PLASTIC SURGEON SINCE PATIENT HAD LEAD/EXTENSION EXPOSED. PATIENT ALSO INDICATED ALL COMPONENTS WILL BE EXPLANTED, LET THE SITE HEAL FOR PERIOD OF TIME, AFTER THE HEALING PROCESS, PATIENT WILL THEN HAVE THE SYSTEM RE-IMPLANT.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388870 ↗
• InjuryFeb 17, 2026Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED AT A LATER DATED THAT PATIENT REQUESTED ASSISTANCE CHECKING THEIR IMPLANT STATUS. AGENT WALKED PATIENT THROUGH CONNECTING TO EACH IMPLANT AND PATIENT REPORTED THAT THERAPY WAS ON FOR BOTH IMPLANTS. PATIENT HAS AN UPCOMING APPOINTMENT WITH A PROVIDER.

  Patient problems: Fall

  MAUDE report 24366483 ↗
• MalfunctionFeb 11, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THEY WENT TO TURN THEIR THERAPY OFF AND THEY COULD NOT GET THE HANDSET SCREEN TO GO OFF, HOWEVER CLARIFICATION REVEALED PATIENT HAD ENCOUNTERED NO COMMUNICATOR FOUND AND THEY HAVE BEEN UNSUCCESSFUL TO RESOLVE IT THEIR THERAPY IS STILL ON. PATIENT SAID THEY WERE INSTRUCTED TO TURN THERAPY OFF AT NIGHT AND BACK ON IN THE MORNING BY THEIR THERAPIST AND WHEN THEY DID THAT IT WAS GREAT THEY GOT A STRONG RESPONSE, THEIR DBS IS STILL OPERATING THEIR HAND IS STEADIER THEIR VOICE IS NOT SO GREAT BUT IT IS WORKING. SINCE THEN THEY'VE BEEN PLUGGING IN THEIR COMMUNICATOR, THEY LEFT OVERNIGHT TO FULLY CHARGE BUT THEN THEY GOT NO COMMUNICATOR FOUND. WORKED WITH PATIENT TO RETRY SEVERAL TIMES/ HOLD DOWN THE COMMUNICATOR POWER BUTTON, PLUG AND UNPLUG, RESTART THE HANDSET AND TOGGLE BLUETOOTH OFF AND BACK ON BUT THE ISSUE WAS NOT RESOLVED. OFFERED AND SENT REQUEST TO REPAIR TO REPLACE THE COMMUNICATOR. ADDITIONAL INFORMATION WAS RECEIVED FROM CALLER AND STATED THAT THEY RECEIVED THE REPLACEMENT COMMUNICATOR BUT THEY ARE STILL NOT ABLE TO CONNECT TO THE HANDSET. AGENT OFFERED THE CALLER ASSISTANCE BUT THE CALLER DID NOT HAVE THEIR EQUIPMENT WITH THEM DURING THE TIME OF CALL. PAT

  Patient problems: Dysphasia; Electric Shock; Sensitivity of Teeth

  MAUDE report 24311079 ↗
• MalfunctionFeb 6, 2026High impedance

  IT WAS REPORTED THAT CONTACT 0 RIGHT STN 3377 OHMS MONOPOLAR CONTACT 0 LEFT STN 2498 OHMS MONOPOLAR BIPOLAR IMPEDANCES WITHIN NORMAL LIMITS FOR BOTH LEADS. PATIENT HAS REPORTED HISTORY OF FALLS. NEITHER CONTACT IS BEING UTILIZED NOW.

  Patient problems: Fall

  MAUDE report 24278348 ↗
• MalfunctionDec 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS DETECTED ON CONTACT 1. PATIENT WAS PROGRAMMED AROUND THIS CONTACT. PATIENT PLANS TO HAVE BATTERY REPLACEMENT DONE DUE TO NORMAL ERI AT WHICH TIME IMPEDANCES WILL BE RETESTED. EXTERNAL CAUSES OF THIS ISSUE REMAIN UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803918 ↗
• InjuryDec 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS IMPLANTS WHICH ONLY LASTED 3 YEARS; HENCE THEY SWITCHED TO RECHARGEABLE WITH 15 YEAR LONGEVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770093 ↗
• InjuryDec 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS IMPLANTS WHICH ONLY LASTED 3 YEARS; HENCE THEY SWITCHED TO RECHARGEABLE WITH 15 YEAR LONGEVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770042 ↗
• InjuryDec 10, 2025Premature Discharge of Battery; Failure to Deliver Energy; Battery Problem; Premature Discharge of Battery; Failure to Deliver Energy; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT THERAPY WAS TURNED ON BY THEIR PHYSICIAN, RESOLVING THE ISSUE. THEY CONFIRM THAT THE PREVIOUS BATTERY DIED AND WAS REPLACED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768676 ↗
• InjuryDec 1, 2025Failure to Deliver Energy; Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Failure to Deliver Energy; Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT DOING MUCH FOR THEM BUT DID NOT ELABORATE ON STATEMENT, AGENT AGAIN REDIRECTED TO HCP REGARDING THERAPY CONCERNS. PATIENT CALLED BACK ELABORATING THAT THEIR THERAPY WENT OFF AND THAT THEY WERE IN A TERRIBLE STATE. DURING THE CALL, AGENT WALKED PATIENT THROUGH SYNCING THEIR CONTROLLER WITH THEIR INS, THEN PATIENT CONFIRMED THAT THEIR THERAPY WAS TURNED OFF AND THAT THEIR CONTROLLER WAS SHOWING ERI. PATIENT THEN STATED THAT THEIR THERAPY WAS WORKING FINE UNTIL THEY TRIED TO ADJUST THEIR THERAPY SETTINGS, AND THAT THEY HAVE NEVER "BEEN LIKE THIS" BEFORE. PATIENT MENTIONED THAT THEY HAVE AN APPOINTMENT WITH THEIR HCP IN DECEMBER SOMETIME, BUT THEY WANTED TO TURN THEIR THERAPY ON FOR THANKSGIVING. PATIENT ADDED THAT THEY WERE ONLY IMPLANTED WITH A NEW "BATTERY" JUST 6 MONTHS AGO BUT DID NOT OPPOSE WHEN AGENT REVIEWED THAT THEIR INS WAS REGISTERED AS IMPLANTED IN 2023 AND DID NOT PROVIDE IMPLANT INFORMATION OTHER THAN THEIR CURRENT REGISTERED IMPLANT. AGENT THEN WALKED PATIENT THROUGH CONNECTING TO THEIR INS AND PATIENT CONFIRMED SEEING THE POOR COMMUNICATION SCREEN. PATIENT WAS ABLE TO SUCCESSFULLY CONNECT TO THEIR INS AND T

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Shaking/Tremors

  MAUDE report 23680777 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POSTOPERATIVE DISCOMFORT. THE PATIENT DEVELOPED AN INFECTION AND REJECTION AT THE STIMULATOR IMPLANTATION SITE. THE WOUND WAS CLEANED. THE ISSUE WAS RESOLVED.

  Patient problems: Discomfort; Foreign Body Reaction; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23680452 ↗
• InjuryNov 18, 2025Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  ADDITIONAL INFORMATION PROVIDED BY REP INDICATING CAUSE REMAINS UNKNOWN AND NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

  Patient problems: Fatigue

  MAUDE report 23587068 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, 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.