Activa® SC 37602 (UDI 00763000100346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00763000100346), received between Mar 30, 2020 and Dec 3, 2025 — classified as 22 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Low impedance” (12 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 59 reports, in the reporter's own words as published by the FDA.

• 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 23712356 ↗
• InjuryDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A MECHANICAL COMPLICATION OF AN IMPLANTED NEUROSTIMULATOR IN THE FINAL DIAGNOSIS. HEALTHCARE PROVIDER (HCP) REPORTED THE IMPLANTABLE NEUROSTIMULATORS (INS) HAD A LOW BATTERY STATUS. ANTIBIOTICS WERE GIVEN PROPHYLACTICALLY BEFORE SURGERY AND NO COMPLICATIONS WERE REPORTED DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679947 ↗
• InjuryDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A MECHANICAL COMPLICATION OF AN IMPLANTED NEUROSTIMULATOR IN THE FINAL DIAGNOSIS. HEALTHCARE PROVIDER (HCP) REPORTED THE IMPLANTABLE NEUROSTIMULATORS (INS) HAD A LOW BATTERY STATUS. ANTIBIOTICS WERE GIVEN PROPHYLACTICALLY BEFORE SURGERY AND NO COMPLICATIONS WERE REPORTED DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679935 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). NO KNOWN ENVIRONMENTAL OR EXTERNAL FACTORS CONTRIBUTING TO THE ISSUE WERE IDENTIFIED, AND NO DIAGNOSTICS OR TROUBLESHOOTING WERE REPORTED. TO ADDRESS THE INFECTION, THE IPG AND A PORTION OF THE EXTENSION WIRE WERE SURGICALLY REMOVED. THE ISSUE WAS RESOLVED FOLLOWING THE INTERVENTION, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL..

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Infection

  MAUDE report 22173089 ↗
• MalfunctionFeb 6, 2025Failure to Deliver Energy; Low impedance; Failure to Deliver Energy; Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE LOW IMPEDANCE WAS NOT KNOWN. ISSUE IS ONGOING, NO ACTIONS WERE TAKEN AS OF NOW TO RESOLVE THE ISSUE.

  Patient problems: Muscular Rigidity

  MAUDE report 21329927 ↗
• InjuryFeb 3, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BATTERY AND EXTENSION REPLACEMENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS "NOT DOING WELL," AND AN IMPEDANCE DIFFERENCE WAS NOTED. AS A RESULT, THE DEEP BRAIN STIMULATION WAS NOT BEING USED DUE TO THE ISSUE. ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE INFORMATION ORIGINALLY PROVIDED IS INCORRECT. THE IMPEDANCES BEFORE THE EXTENSION/BATTERY REPLACEMENT IN ATLANTA, GEORGIA WERE ALREADY OUT OF RANGE. THERE WERE NO CHANGES IN IMPEDANCES BEFORE AND AFTER THE EXTENSION/BATTERY EXTENSION PROCEDURE. REP CONFIRMED THE DEVICE IS OPERATING AS IT SHOULD AND IS IMPLANTED AND IN USE. REP NOTED THE HEALTHCARE PROVIDER (HCP) REQUESTED A PHONE CALL TO BRIEFLY DISCUSS ABOUT THE PATIENT'S SITUATION. ADDITIONAL INFORMATION WAS REPORTED BY THE REP CONFIRMING THE PHONE CALL REQUEST HAS BEEN TAKEN CARE OF AND IF THERE ARE FURTHER ISSUES, THEY WILL REPORT BACK.

  Patient problems: Insufficient Information

  MAUDE report 21300218 ↗
• MalfunctionJul 10, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE PATIENT PROGRAMMER (PP) WASN¿T TURNING ON. THE CONSUMER USED NEW BATTERIES, BUT THE SCREEN WAS BLANK, AND THE ISSUE WASN¿T RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709868 ↗
• InjuryApr 15, 2024Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem

  DOCTOR DISCOVERED A SHORT ON THE 1 MONOPOLAR ELECTRODE. THIS IS THE ELECTRODE PROGRAMMING FOR THE PATIENT. PATIENT SAID SHE FELT SOMETHING SHOCK A LITTLE AT THE IPG IMPLANT SIGHT AT SOME POINT AND THEN THE BATTERY LIFE STARTED GOING DOWN FASTER. AN IMPEDANCE TEST WAS RAN AND DOCTOR DISCOVERED THE SHORT IN THE EXTENSION NEAR THE IPG IMPLANT SIGHT. HE DECIDED TO REPLACE THE EXTENSION, WHICH RESOLVED THE SHORT.

  Patient problems: Electric Shock

  MAUDE report 19111321 ↗
• MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PROVIDER HAD CHECKED BATTERY VOLTAGE A COUPLE WEEKS AGO. THEN A COUPLE WEEKS AGO, CALLER CHECKED THE VOLTAGE AND RIGHT SIDE INS IS 3.60V AND LEFT AT 3.0V. AND THAT IS A HIGHER NUMBER THAN WHAT THE DOCTOR HAD SAID THE VOLTAGE WAS AT A COUPLE WEEKS AGO. TROUBLESHOOTING COULD NOT BE DONE AS PATIENT WAS NOT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983892 ↗
• MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PROVIDER HAD CHECKED BATTERY VOLTAGE A COUPLE WEEKS AGO. THEN A COUPLE WEEKS AGO, CALLER CHECKED THE VOLTAGE AND RIGHT SIDE INS IS 3.60V AND LEFT AT 3.0V. AND THAT IS A HIGHER NUMBER THAN WHAT THE DOCTOR HAD SAID THE VOLTAGE WAS AT A COUPLE WEEKS AGO. TROUBLESHOOTING COULD NOT BE DONE AS PATIENT WAS NOT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983844 ↗
• MalfunctionJan 31, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WILL NOT TURN ON. TRIED NEW BATTERIES BUT WILL NOT TURN ON. EMAIL WAS SENT TO REPAIR TO REPLACE THE DEVICE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615442 ↗
• MalfunctionJan 31, 2024Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER HAS NOT WORKED FOR A COUPLE OF YEARS, THE SCREEN IS DARK AND BLANK DESPITE CHANGING THE BATTERIES. CALLER CHECKED THE BATTERY COMPARTMENT AND REPORTED IT LOOKED JUST FINE. CALLER SAID WHEN THE BATTERIES ARE CHANGED, REPLACED WITH BRAND NEW ONES AND PLACED IN THE BATTERY COMPARTMENT THE CORRECT WAY IT DOES NOT POWER UP. THEY'VE BEEN USING THE OTHER ONE FOR A COUPLE OF YEARS INSTEAD AND JUST FOUND OUT THEY COULD GET THIS ONE REPLACED. THE ISSUE WAS NOT RESOLVED. A REPLACEMENT DEVICE WILL BE MAILED TO THE PATIENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614102 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT WAS AT HCP WHEN IT WAS FOUND THAT THE PATIENT PROGRAMMER WOULDN'T POWER ON, NEW BATTERIES DIDN'T RESOLVE THE ISSUE. A REPLACEMENT PROGRAMMER WAS SENT OUT. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608736 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT RECHARGER NOT POWERING ON. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE ASKED BUT UNKNOWN. DESKTOP CHARGER WAS NOT BENT, LOOSE OR BROKEN GREEN LIGHT IS ON POWER CORD. NO DAMAGE SEEN INSIDE RECHARGER PORT. THE ISSUE WAS NOT RESOLVED. A REPLACEMENT RECHARGER WILL BE SENT TO THE PATIENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608179 ↗
• InjuryJan 10, 2024Break; High impedance; Break; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE HIGH IMPEDANCES WAS DUE TO VISIBLE DAMAGE OF THE LEAD NEAR THE EXTENSION CONNECTION CONTACTS. THE EXTENSION AND NEUROSTIMULATOR WERE REPLACED, BUT THE IMPEDANCE ISSUE WASN¿T RESOLVED SO THE PATIENT WAS GOING TO MONITOR FOR CHANGES.

  Patient problems: Wound Dehiscence

  MAUDE report 18486352 ↗
• MalfunctionNov 9, 2023Low impedance; Low impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE LOW IMPEDANCES WASN¿T DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108224 ↗
• MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THEY WENT TO THE HEALTHCARE PROVIDERS (HCPS) A COUPLE WEEKS AGO TO HAVE THEIR THERAPY ADJUSTED AND STATED IT WAS BETTER BUT SAID THE THERAPY WAS "STILL NOT RIGHT" AND THERAPY HASN'T BEEN ADEQUATE. THE PATIENT STATED THEY ARE ABLE TO ADJUST THEIR THERAPY UP/DOWN TWO BUT STATED IT ISN'T ENOUGH. PSS INFORMED THE PATIENT THE UPPER AND LOWER LIMITS ARE SET BY THE HCP AND IF THEY WANT DIFFERENT PARAMETERS THEY WOULD NEED TO DISCUSS IT FURTHER WITH THEIR HCP. THE PATIENT STATED THAT THE HCP DID INFORM THEM THAT THE HIGHER THE VOLTAGE THE QUICKER THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WOULD DIE. PSS DID INFORM THE PATIENT THAT THE MANUFACTURER OFFERS A RECHARGEABLE INS THAT THEY COULD DISCUSS WITH THEIR HCP TO SEE IF THE RECHARGEABLE INS WOULD BE A GOOD FIT FOR THEM. THE PATIENT STATED THAT THE THERAPY IS NOT ENOUGH AND DOES NOT CONTROL THE TREMORS AS MUCH AS THEY WOULD LIKE , AND THEY STILL NEED TO TAKE PRIMADOL IN ADDITION TO THE DBS. THE PATIENT STATED THEY HAVE HAD TREMORS SINCE BEFORE 2008 AND HAVE NOT SUBSIDED. THE PATIENT STATED THEY THOUGHT OVER THE YEAR THEY WOULD GET THE DBS DOWN TO HAVE NO TREMORS. FOR OTHER SYMPTOMS THE PATIENT STATED TO HAVING APH

  Patient problems: Dysphasia; Shaking/Tremors

  MAUDE report 16961784 ↗
• MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED, THAT THEY WENT TO THE HEALTHCARE PROVIDERS (HCPS) A COUPLE WEEKS AGO TO HAVE THEIR THERAPY ADJUSTED. AND STATED IT WAS BETTER, BUT SAID THE THERAPY WAS "STILL NOT RIGHT" AND THERAPY HASN'T BEEN ADEQUATE. THE PATIENT STATED, THEY ARE ABLE TO ADJUST THEIR THERAPY UP/DOWN TWO. BUT STATED, IT ISN'T ENOUGH. PSS INFORMED THE PATIENT, THE UPPER AND LOWER LIMITS ARE SET BY THE HCP AND IF THEY WANT DIFFERENT PARAMETERS THEY WOULD NEED TO DISCUSS IT FURTHER WITH THEIR HCP. THE PATIENT STATED, THAT THE HCP DID INFORM THEM THAT THE HIGHER THE VOLTAGE, THE QUICKER THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WOULD DIE. PSS DID INFORM THE PATIENT, THAT THE MANUFACTURER OFFERS A RECHARGEABLE INS THAT THEY COULD DISCUSS WITH THEIR HCP TO SEE IF THE RECHARGEABLE INS WOULD BE A GOOD FIT FOR THEM. THE PATIENT STATED, THAT THE THERAPY IS NOT ENOUGH AND DOES NOT CONTROL THE TREMORS AS MUCH AS THEY WOULD LIKE. AND THEY STILL NEED TO TAKE PRIMADOL IN ADDITION TO THE DBS. THE PATIENT STATED, THEY HAVE HAD TREMORS SINCE BEFORE 2008 AND HAVE NOT SUBSIDED. THE PATIENT STATED, THEY THOUGHT OVER THE YEAR THEY WOULD GET THE DBS DOWN TO HAVE NO TREMORS. FOR OTHER SYMPTOMS, THE PATIENT STATED,

  Patient problems: Dysphasia; Shaking/Tremors

  MAUDE report 16961586 ↗
• MalfunctionMay 5, 2023Low impedance; Low impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE NEUROLOGIST DISCOVERED THE SHORT CIRCUIT ON (B)(6) 2022. THE CAUSE OF THE SHORT CIRCUIT WAS UNKNOWN, AND AFTER RUNNING IMPEDANCES MULTIPLE TIMES THE SHORT DIDN¿T RESOLVE. THE PHYSICIAN WAS CURIOUS OF GETTING A SPECIFIC VALUE FOR THE SHORT, BUT SINCE THE SHORT WASN¿T AN ACTIVE CONTACT FOR THAT PARTICULAR PATIENT¿S SETTINGS, IT WASN¿T MUCH OF A CONCERN FOR THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876810 ↗
• InjuryApr 28, 2023Loss of Data; Data Problem; Loss of Data; Data Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE DEVICE SETUP AND ACTIVATION ISSUE WAS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834727 ↗
• InjuryMar 31, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT REPRESENTATIVE CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY MID (B)(6) 2023 AND THE VOLTAGE WAS AT 2.67, AND WHEN THEY CHECKED IT AGAIN IN (B)(6) 2023 THE VOLTAGE WAS AT 2.56. CALLER FELT LIKE THE VOLTAGE WAS DROPPING RAPIDLY. THE CALLER REPORTED THAT THEY HAVE A SURGERY TO REPLACE THE LEFT INS ON (B)(6) 2023 AND WANTED TO KNOW WHAT THE EOS VOLTAGE OF INS IS. AGENT REVIEWED THAT EOS IS 2.2V.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656509 ↗
• MalfunctionMar 15, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) CALLED THE PATIENT'S ECF AT THE REQUEST OF THE NEUROSURGEON AND TALKED THE NURSE THROUGH CHECKING IPG WITH THE PATIENT'S PROGRAMMER (PP). THE DBS WAS OFF, SO THEY TURNED IT BACK ON. THE NURSE CALLED THE REP AN HOUR LATER, INDICATING THAT THE PATIENT COMPLAINED OF PAIN AND ASKED FOR DBS TO BE TURNED OFF. THE PATIENT'S NEUROLOGIST NO LONGER WORKS WITH DBS, WILL NOT SEE THEM, AND ADVISED THE ECF TO CALL THE REP. THE REP WILL SEE THE PATIENT TOMORROW (B)(6) 2023 TO INTERROGATE THEIR SYSTEM AND RECOMMEND ANOTHER NEUROLOGY PROVIDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT SAW THE PATIENT AND INTERROGATED THE DBS. THE PATIENT STILL COMPLAINED OF FEELING "FUNNY" BUT WANTED TO KEEP DBS ON TO CONTROL RIGHT-HAND TREMORS. THE IMPEDANCE VALUES WERE NORMAL. THE SETTINGS WERE LOWERED SLIGHTLY AT THE PATIENT AND THEIR ECF NURSE'S REQUEST, AND THEY SAID IT WAS BETTER. GAVE THEM THE NAME OF THE CLOSEST DBS MANAGING NEUROLOGIST SINCE THEIRS NO LONGER WORKS WITH DBS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THE CAUSE OF THE THERAPY BEING OFF WAS UNKNOWN AND CONFIRMED THAT THE PATIENT'S SYMPTOMS (PAIN, RIGHT-HAND TREM

  Patient problems: Insufficient Information; Pain

  MAUDE report 16542927 ↗
• MalfunctionMar 3, 2023Energy Output Problem; Battery Problem; Energy Output Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE IMPLANTS DIDN¿T WORK AS WELL WHEN THEY WERE NEARING END OF SERVICE, AND THE PATIENT DIDN¿T WALK WAS WELL WHEN THE IMPLANT REACHED THE ERI STATUS AS THEY WEREN¿T AS STABLE AND WERE A LITTLE STIFFER. THE CONSUMER INCREASED STIMULATION BY 0.02 IN THOSE SITUATIONS WHICH MADE THE BATTERIES DEPLETE FASTER. WHEN ONE IMPLANT REACHED EOS THE PATIENT FROZE IN THE HALLWAY AT 2 IN THE MORNING THE DAY PRIOR TO WHEN THEY WERE SUPPOSED TO HAVE THE IMPLANT REPLACED SO THEY GAVE THE PATIENT A MEDICATION AND WAITED AN HOUR BEFORE THEY COULD GET THE PATIENT TO MOVE. THE PATIENT¿S CURRENT BATTERY VOLTAGE WAS 2.63 (WAS NOT AT ERI YET). THE PATIENT WAS DUE TO HAVE THE IMPLANT REPLACED ON (B)(6) 2023.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Muscular Rigidity

  MAUDE report 16477318 ↗
• MalfunctionJan 8, 2023Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER REPORTED THEY DIDN'T KNOW WHAT LED TO THE ¿JOLT.¿ THE CONSUMER NOTED THEY DIDN'T BELIEVE THE FALL THE PATIENT EXPERIENCED WAS RELATED TO THE REPLACEMENT OF THE IMPLANT (REPLACED DUE TO NORMAL BATTERY DEPLETION).

  Patient problems: Electric Shock; Shaking/Tremors

  MAUDE report 16119576 ↗
• MalfunctionDec 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY FOR INS REPLACEMENT DUE TO THE NORMAL LIFE SPAN OF THE DEVICE. WHEN CHECKING IMPEDANCE BEFORE THE SURGERY, CONTACT 3 WAS HIGH. RAN IMPEDANCE AT 1.5 V AND 3 V WITH NO CHANGE. WHEN THE NEW INS WAS PLACED, IMPEDANCES ON CONTACT 3 REMAINED HIGH. THE PATIENT WAS NOT PROGRAMMED WITH THAT CONTACT. THE FACTORS THAT MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE WERE UNKNOWN. THE ISSUE WAS NOT RESOLVED. NO SYMPTOMS/COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983930 ↗

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.