Activa® SC 37602 (UDI 00763000519223)Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00763000519223), received between Jul 8, 2022 and Aug 18, 2026 — classified as 39 injuries, 46 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Premature Discharge of Battery

  It was reported that the caller said the patient (pt) had their right battery replaced in April and at that time the left battery was at 100%. Caller said 3 weeks ago the battery dropped to 75% and the next week it dropped to 50% then in a few days it dropped to 0. Caller saw an EOS message on the pt programmer. Caller said the healthcare provider (HCP) told them it was very unusual for the INS battery to deplete this fast. PSS reviewed the implantable neurostimulator (INS) battery level doesn't show a percentage that it shows ok or low and a voltage. Patient Services (PSS) asked if they could have been looking at the patient programmer battery level. Caller communicated w/ the INS and saw an EOS message which they were not able to bypass. Caller said the pt is completely immobile because the INS is depleted. Caller got a call from a nurse and had to end the call.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 50308454 ↗
• MalfunctionJul 8, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED AFTER ITS USE BEFORE DATE (UBD). THE IMPLANT DATE WAS (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748905 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (PT) SCHEDULED FOR ROUTINE BATTERY CHANGE (ERI) FOR LEFT IMPLANT. NOTICED LUMP ON NECK AND SWELLING AT IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THERE WAS A CONCERN FOR INFECTION, CULTURES WERE TAKEN AND THE LEFT SYSTEM WAS EXPLANTED. MANUFACTURER REPRESENTATIVE (REP) INDICATES THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information; Swelling/ Edema; Unspecified Infection

  MAUDE report 25152991 ↗
• MalfunctionApr 27, 2026High impedance; Unintended Collision

  IT WAS REPORTED THAT CONTACT 0 DISPLAYING IMPEDANCE VALUES > 20,000 OHMS. NO SYMPTOMS TO PATIENT AS A RESULT OF HIGH IMPEDANCES. PATIENT IS PROGRAMMED IN BIPOLAR CONFIGURATION W 2 - AND 3 + . IMPEDANCES HAVE BEEN HIGH ON LEFT SIDE EVER SINCE A MAJOR CAR ACCIDENT SEVERAL YEARS AGO. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. REP NOTED THE HIGH IMPEDANCE HAS NOT AFFECTED THE PATIENT'S THERAPY. REP REPORTS THE CAUSE OF THE IMPEDANCES IS NOT KNOWN AND NO TROUBLESHOOTING WILL BE DONE BY THE HEALTHCARE PROVIDER (HCP). THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE REPLACEMENT OF THE TWO IMPLANTABLE NEUROSTIMULATORS WAS DUE TO NORMAL BATTERY DEPLETION RATHER THAN HIGH IMPEDANCE. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002915 ↗
• MalfunctionApr 27, 2026High impedance; Unintended Collision

  IT WAS REPORTED THAT CONTACT 0 DISPLAYING IMPEDANCE VALUES > 20,000 OHMS. NO SYMPTOMS TO PATIENT AS A RESULT OF HIGH IMPEDANCES. PATIENT IS PROGRAMMED IN BIPOLAR CONFIGURATION W 2 - AND 3 + . IMPEDANCES HAVE BEEN HIGH ON LEFT SIDE EVER SINCE A MAJOR CAR ACCIDENT SEVERAL YEARS AGO. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. REP NOTED THE HIGH IMPEDANCE HAS NOT AFFECTED THE PATIENT'S THERAPY. REP REPORTS THE CAUSE OF THE IMPEDANCES IS NOT KNOWN AND NO TROUBLESHOOTING WILL BE DONE BY THE HEALTHCARE PROVIDER (HCP). THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE REPLACEMENT OF THE TWO IMPLANTABLE NEUROSTIMULATORS WAS DUE TO NORMAL BATTERY DEPLETION RATHER THAN HIGH IMPEDANCE. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002512 ↗
• MalfunctionMar 25, 2026High impedance; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT FELT A TINGLING SENSATION WHILE SEATED AT HER GRANDCHILD'S CRAFT FAIR. HER DEVICE WAS CHECKED TODAY IN CLINIC. IT WAS ON AND THE IMPEDANCES WERE NORMAL. AFTER INSTRUCTING THE PATIENT TO TURN HER HEAD WHILE ANOTHER IMPEDANCE CHECK WAS DONE, IT SHOWED CONTACT 0 WAS 2,252 OHMS. PATIENT DENIED ANY FALLS OR ANYTHING EMI AROUND HER AT THE TIME OF THE TINGLING EPISODE. THE PROVIDER ORDERED FOR HER TO GET XRAYS.

  Patient problems: Paresthesia

  MAUDE report 24687759 ↗
• MalfunctionFeb 26, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE CALL, CONFIRMED THAT THEIR CURRENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING AND THAT THEY'VE BEEN IN TOUCH WITH THEIR HEALTHCARE PROVIDER (HCP), BUT THEY "WANTED SOMETHING" WHILE THEIR HCP DIDN'T "WANT IT". PATIENT MENTIONED THAT THE "WIRES" ON THEIR HEAD WERE MOVING AROUND, AND THAT THEY DIDN'T THINK THEIR INS HAS BEEN MOVED, BUT THEY'VE FALLEN A TIME OR TWO. AGENT TRIED TO REVIEW GENERAL THERAPY INFORMATION, ROLE OF PATIENT SERVICES, AND TO REDIRECT THE PATIENT TO THEIR HCP, BUT PATIENT KEPT CUTTING THE AGENT OFF. WHEN AGENT WAS TRYING TO COLLECT EVENT INFORMATION, PATIENT KEPT CUTTING THE AGENT OFF BY CLOSING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462526 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT PATIENT HAD A BILATERAL INS REPLACEMENT DUE TO NORMAL ELECTIVE REPLACEMENT INTERVAL. REP REPORTED THAT BOTH DEVICES WERE SHOWING ERI. REP REPORTED THAT TWO NEW DEVICES WERE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348074 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT PATIENT HAD A BILATERAL INS REPLACEMENT DUE TO NORMAL ELECTIVE REPLACEMENT INTERVAL. REP. REPORTED THAT BOTH DEVICES WERE SHOWING ERI. REP REPORTED THAT TWO NEW DEVICES WERE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348031 ↗
• MalfunctionFeb 13, 2026Disconnection; High impedance

  THE MANUFACTURER'S REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE LEFT NEUROSTIMULATOR WAS ALSO REPLACED DUE TO NORMAL BATTERY DEPLETION AND DISPLAYED AN IMPEDANCE OF 3,084 OHMS AT CONTACT 1. AFTER REPLACEMENT, THE NEW INS DISPLAYED NORMAL IMPEDANCES. PATIENT'S FAMILY WAS INFORMED THAT THE PATIENT'S IPG'S HAVE NORMAL IMPEDANCES AND THAT THE PATIENT IS ELIGIBLE FOR HEAD ONLY MRI.

  Patient problems: Insufficient Information

  MAUDE report 24338694 ↗
• 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 24278429 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT'S LEFT INS AND LEFT EXTENSION WERE EXPLANTED DUE TO INFECTION. LEFT BRAIN IS NOT INFECTED. THE PLAN IS TO IMPLANT A NEW INS AND EXTENSION ONCE PATIENT HAS RECOVERED FROM THE INFECTION.

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 23990068 ↗
• 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 23957425 ↗
• MalfunctionDec 19, 2025Low impedance; Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT DURING REPLACEMENT OF RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS), IMPEDANCE WITHIN NORMAL LIMITS PRE OP. DURING REPLACEMENT, IMPEDANCES ON CONTACT 0 AND 3 WERE LOW AS OCCURRED IN ORIGINAL EVENT IN 2022. THESE CONTACTS ARE NOT BEING USED FOR THERAPY; THUS NO ADDITIONAL ACTIONS ARE PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851995 ↗
• MalfunctionDec 12, 2025High impedance; Electromagnetic Compatibility Problem; High impedance; Electromagnetic Compatibility Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT IT WAS UNKNOWN WHEN ELEVATED IMPEDANCES STARTED.

  Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795040 ↗
• MalfunctionDec 3, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS)- DUE TO NORMAL BATTERY DEPLETION - AN OUT OF RANGE (OOR) IMPEDANCE WAS DETECTED ON CONTACT 3 OF THE LEAD. VALUES WERE MEASURED AT 162 MONOPOLAR CONTACT 3 L STN. THE IMPEDANCE ON THIS CONTACT WAS WITHIN RANGE UPON FIRST CONNECTING THE BATTERY BUT RESULTED IN AN OOR VALUE AFTER A SECOND CHECK. PATIENT RECORDS NOTED A HISTORY OF INTERMITTENT IMPEDANCES ON THIS CONTACT. PATIENT WAS NOT CURRENTLY RECEIVING THERAPY ON THIS CONTACT. NO FURTHER ACTION WAS PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712359 ↗
• InjuryOct 28, 2025Unintended Collision; Adverse Event Without Identified Device or Use Problem; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM HCP INDICATING THAT DEVICE, THERAPY, AND PROCEDURE WAS NOT CAUSAL OR CONTRIBUTORY TO THE BUZZING IN THE HEAD, SPASMS, VACANT LOOK, WEAKNESS, OR PRESSURE IN THE HEAD. PATIENT HAS HAD SEVERAL FALLS IN THE MONTHS FOLLOWING DEVICE REPLACEMENT. CT SCAN SHOWED NO CHANGE FROM PREVIOUS. SEIZURE WAS NOT CONFIRMED. CAUSE OF FALLING ATTRIBUTED TO ORTHOSTATIC HYPOTENSION. NO THERAPY OR DEVICE INVOLVED INTERVENTIONS WERE TAKEN IN RESPECT TO THE PREVIOUSLY LISTED ISSUES. THEY ARE TRYING TO WORK ON MANAGING HIGH BLOOD PRESSURE. DEVICE IS ON WITH THERAPY OPERATING.

  Patient problems: Fall; Head Injury; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 23405871 ↗
• InjuryOct 28, 2025Unintended Collision; Adverse Event Without Identified Device or Use Problem; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM HCP INDICATING THAT DEVICE, THERAPY, AND PROCEDURE WAS NOT CAUSAL OR CONTRIBUTORY TO THE BUZZING IN THE HEAD, SPASMS, VACANT LOOK, WEAKNESS, OR PRESSURE IN THE HEAD. PATIENT HAS HAD SEVERAL FALLS IN THE MONTHS FOLLOWING DEVICE REPLACEMENT. CT SCAN SHOWED NO CHANGE FROM PREVIOUS. SEIZURE WAS NOT CONFIRMED. CAUSE OF FALLING ATTRIBUTED TO ORTHOSTATIC HYPOTENSION. NO THERAPY OR DEVICE INVOLVED INTERVENTIONS WERE TAKEN IN RESPECT TO THE PREVIOUSLY LISTED ISSUES. THEY ARE TRYING TO WORK ON MANAGING HIGH BLOOD PRESSURE. DEVICE IS ON WITH THERAPY OPERATING.

  Patient problems: Fall; Head Injury; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 23405869 ↗
• InjuryOct 28, 2025Electromagnetic Interference; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Electromagnetic Interference; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE PATIENT WAS DIAGNOSED WITH RIGHT SIDE CERVICAL OCCIPITAL NEURALGIA. SOME OF THE NERVES ARE INFLAMED AND CAUSING PAIN ON THE RIGHT SIDE. THEY WANT TO SEND THE PATIENT TO PHYSICAL THERAPY BUT THE PATIENT IS WORRIED ABOUT THE LEADS. REVIEWED COMPATIBILITY AND OBTAINING FROM MASSAGING OVER THE LEADS. AGENT ASKED IF THE DIAGNOSIS WAS RELATED TO THE DEVICE OR THERAPY. THE PATIENT REP SAID IT IS PROBABLY RELATED TO THE FALL THEY HAD RECENTLY. ONE STIMULATOR BECAME LOW. TWO DAYS BEFORE SURGERY THEY FELL ON HEAD AND HEAD WAS BENT TO THE RIGHT. IT HAS BEEN PERSISTENT. THEY HOLD THEIR HEAD TO THE RIGHT, IT IS PAINFUL, AND THEY HAVE HEADACHES.

  Patient problems: Cognitive Changes; Convulsion/Seizure; Discomfort; Headache; Inflammation; Insufficient Information; Muscle Weakness/Atrophy; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23405834 ↗
• InjuryOct 28, 2025Electromagnetic Interference; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Electromagnetic Interference; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE PATIENT WAS DIAGNOSED WITH RIGHT SIDE CERVICAL OCCIPITAL NEURALGIA. SOME OF THE NERVES ARE INFLAMED AND CAUSING PAIN ON THE RIGHT SIDE. THEY WANT TO SEND THE PATIENT TO PHYSICAL THERAPY BUT THE PATIENT IS WORRIED ABOUT THE LEADS. REVIEWED COMPATIBILITY AND OBTAINING FROM MASSAGING OVER THE LEADS. AGENT ASKED IF THE DIAGNOSIS WAS RELATED TO THE DEVICE OR THERAPY. THE PATIENT REP SAID IT IS PROBABLY RELATED TO THE FALL THEY HAD RECENTLY. ONE STIMULATOR BECAME LOW. TWO DAYS BEFORE SURGERY THEY FELL ON HEAD AND HEAD WAS BENT TO THE RIGHT. IT HAS BEEN PERSISTENT. THEY HOLD THEIR HEAD TO THE RIGHT, IT IS PAINFUL, AND THEY HAVE HEADACHES.

  Patient problems: Cognitive Changes; Convulsion/Seizure; Discomfort; Headache; Inflammation; Insufficient Information; Muscle Weakness/Atrophy; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23405775 ↗
• InjurySep 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A PROCEDURE TO REPLACE THE RIGHT IMPLANTABLE PULSE GENERATOR (IPG), THE NEW BATTERY WAS TESTED AND FOUND TO HAVE HIGH IMPEDANCES (OVER 40,000) ON CONTACTS ZERO AND THREE. IMPEDANCES WERE CHECKED MULTIPLE TIMES ON BOTH THE OLD AND NEW BATTERIES, WITH HIGH VALUES CONSISTENTLY OBSERVED ON CONTACTS ZERO AND THREE. TO RULE OUT A DEFECTIVE GENERATOR, A SECOND NEW BATTERY WAS OPENED AND TESTED; HOWEVER, HIGH IMPEDANCES PERSISTED ON THE SAME CONTACTS. THE PATIENT¿S BATTERY WAS PROGRAMMED USING CONTACTS ONE AND TWO, WHICH HAD NORMAL IMPEDANCES. THE ISSUE WAS RESOLVED BY USING THE FUNCTIONAL CONTACTS, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL. THE EVENT OCCURRED DURING THE IPG REPLACEMENT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059624 ↗
• MalfunctionSep 3, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT IT WAS DECIDED TO PROCEED WITH REVISION/REPLACEMENT OF RIGHT LEAD, EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS). DATE IS TO BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951433 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2025-AUG-01 (B)(6) PATIENT REGISTRATION (B)(6) (CON): IT WAS REPORTED THAT THE STIMULATOR WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22807709 ↗
• InjuryAug 12, 2025Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT HAD JUST GOTTEN GOT A NEW BATTERY FOR THEIR IMPLANT TODAY BECAUSE THE PREVIOUS BATTERY HAD DIED PRETTY QUICKLY SO THE PATIENT HAD IT REPLACED WITH A RECHARGEABLE IMPLANT AND THEY HAD QUESTIONS ABOUT THE PATIENT'S NEW RECHARGER, COMMUNICATOR, AND HANDSET. CALLER STATED THAT THE INS BATTERY HADN'T BEEN ENTIRELY DEPLETED BUT NOTED IT WAS CLOSE TO IT AND THAT IT THEY WERE MADE AWARE THE BATTERY WAS LOW PROBABLY A MONTH OR TWO MONTHS AGO. CALLER STATED WHEN THE PATIENT'S MOST RECENT IMPLANT FROM (B)(6) 2025 DIED, THE PATIENT WOULD ALSO REPLACE THAT ONE WITH A RECHARGEABLE INS AS WELL BECAUSE THE PATIENT NEEDED A RECHARGEABLE IMPLANT FROM NOW ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784134 ↗
• InjuryJul 31, 2025Break; Impedance Problem; Break; Impedance Problem

  IT WAS REPORTED THAT IMPEDANCE ISSUES WERE IDENTIFIED DURING PREOPERATIVE TESTING. UPON EXPLORATION, IT WAS DISCOVERED THAT THE EXTE NSION WIRE WAS BROKEN IN MULTIPLE PLACES. SURGICAL INTERVENTION WAS PERFORMED TO REMOVE AND REPLACE THE EXTENSION, RESOLVING THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683819 ↗

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-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.