Activa® SC 37602 (UDI 00763000384333)Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00763000384333), received between Apr 16, 2021 and Dec 1, 2025 — classified as 22 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (14 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT REPORTED THAT CAUSE OF EOS WAS UNKNOWN AS THEY THOUGHT THEY HAD 6 MONTHS LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680922 ↗
• MalfunctionNov 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT, INDICATING THAT THE BATTERY WAS A FIVE (5) YEARS OLD DEVICE THAT AND WENT OUT DUE TO NORMAL BATTERY DEPLETION. THE REPLACEMENT DATE WAS (B)(6) 2025. THE ISSUE WAS RESOLVED.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 23464782 ↗
• MalfunctionNov 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT, INDICATING THAT THE BATTERY WAS A FIVE (5) YEARS OLD DEVICE THAT AND WENT OUT DUE TO NORMAL BATTERY DEPLETION. THE REPLACEMENT DATE WAS (B)(6) 2025. THE ISSUE WAS RESOLVED.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 23464770 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PRE-OPERATIVE DIAGNOSIS OF SURGICAL SITE INFECTION AND BATTERY EROSION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 21878113 ↗
• 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 21300186 ↗
• MalfunctionJan 25, 2025Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE ZAPPING/TINGLING SENSATION DURING RECHARGING WAS RESOLVED WHEN REP ATTEMPTED TO CHARGE. THERE HAS BEEN NO COMPLAINT BY THE PATIENT AND NO DISCOMFORT SEEN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Paresthesia

  MAUDE report 21236120 ↗
• InjuryJan 24, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT ABOUT 2 MONTHS AGO THE IMPLANT BATTERY UNEXPECTEDLY DIED WITHOUT WARNING. THEY TO GO TO THE EMERGENCY ROOM AND IT WAS VERY LAST MINUTE. THEY STATED THAT THE NEUROLOGIST THAT THEY HCP WAS VERY SURPRISED BY THIS. THEY WANTED TO CHECK THE STATUS OF INS BATTERY WITH HANDSET/TM90. PATIENT SERVICES WALKED THE PATIENT THROUGH THE STEPS OF CONNECTING TO DBS THERAPY APP. PATIENT SERVICES REVIEWED ERI/EOS AND BATTERY LONGEVITY EXPECTATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21226809 ↗
• MalfunctionSep 12, 2024High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT UPON INTERROGATING PREVIOUS DEVICE, THE PATIENT HAD HIGH IMPEDANCES ON 2ND AND 3RD CONTACTS IN MONOPOLAR CONFIGURATION AT 2575 AND 9188 OHMS RESPECTIVELY. THE PATIENT DID NOT COMPLAIN OF ANY SYMPTOMS. THE BATTERY WAS REPLACED, AND THE HIGH IMPEDANCE ON 2ND CONTACT WAS RESOLVED, BUT 3RD CONTACT REMAINED HIGH AT 7565 OHMS. TO RESOLVE THE ISSUE, THE BATTERY WAS REMOVED, AND A WET AND DRY TOWEL WERE APPLIED TO THE ELECTRODES. IMPEDANCES REMAINED HIGH ON THE 3RD CONTACT. THE ISSUE WAS NOT RESOLVED BY THE TIME OF THIS REPORT. THE HCP HAS NO FURTHER INFORMATION. THE PATIENT WAS ALIVE AND HAD NO INJURY AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208488 ↗
• MalfunctionMay 3, 2024Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

  PATIENT REPORTED THAT THEY WERE HAVING SOME TINGING DOWN THEIR ARM (DIDN'T ALLEGE THIS WAS DEVICE RELATED) SO THEIR DOCTOR SUGGESTED THEY HAVE AN EMG/NERVE CONDUCTION STUDY. PATIENT SAID THEY HAD AN EMG/NERVE CONDUCTION STUDY ONCE BEFORE ON 2021-01-04 AND IT WAS NOT GOOD BECAUSE DURING THE TESTING, PATIENT SAID THEY FELT A JOLTING/SHOCKING SENSATION NOT JUST IN THEIR ARM WHERE THEY WERE DOING THE STUDY BUT THROUGH THEIR WHOLE BODY. THEY SAID IT WAS THE MOST UNBELIEVABLY PAINFUL THING THAT THEY'VE HAD DONE ON THEM AND IT WENT AWAY WHEN THE TEST STOPPED. PATIENT SAID THEY THINK THIS HAD HAPPENED BECAUSE THEIR DBS DEVICE WAS BEING INTERFERED WITH BY THE EMG/NERVE CONDUCTION STUDY BUT THE PATIENT'S NEUROLOGIST WAS SAYING THAT WOULDN'T BE THE CASE. PATIENT ASKED ABOUT EMG/NERVE CONDUCTION TEST COMPATIBILITY INFO. PATIENT SERVICES REVIEWED INFO AND REDIRECTED PATIENT TO THEIR DOCTOR.

  Patient problems: Electric Shock; Pain

  MAUDE report 19242668 ↗
• MalfunctionApr 24, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT'S PROGRAMMER IS NOT POWERING ON. CALLER HAS TRIED 3 SETS OF NEW BATTERIES BUT THAT DID NOT RESOLVE THE ISSUE. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174593 ↗
• MalfunctionFeb 12, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD BILATERAL IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT DUE TO NORMAL BATTERY DEPLETION. THE L EFT INS SHOWED IMPEDANCES OF OVER 15,000 OHMS FOR CONTACT 0 AND ALL BIPOLAR CONFIGURATIONS WITH CONTACT 0. THE PATIENT¿S PROGRAMMED SETTINGS DO NOT INVOLVE CONTACT 0 SO THERE WAS NO IMPACT ON THEIR THERAPY. FOLLOWING THE REPLACEMENT OF NEW LEFT INS, IMPEDANCES READ OVER 15,000 OHMS FOR CONTACT 0 AND ALL BIPOLAR CONFIGURATIONS WITH CONTACT 0. NO INTERVENTION WAS TAKEN BESIDES REPLACING THE INS. THE ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE CAUSE OF THE HIGH IMPEDANCE WAS UNABLE TO BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691418 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHAKING ALL OVER. PATIENT INITIALLY MENTIONED MONDAY WHEN AGENT ASKED FOR THE EVENT DATE AND P ATIENT ALSO MENTIONED "WAKING UP WITH THIS" TODAY. PATIENT WANTED TO CHECK THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE THE PATIENT PROGRAMMER (PP) BUT WAS UNABLE TO DO SO BECAUSE THE PP WOULDN'T POWER ON.  PATIENT TRIED TO REPLACE BATTERIES BUT COULDN'T BECAUSE THE BATTERY COMPARTMENT DOOR WAS STUCK AND WOULDN'T OPEN. PATIENT STATED PRIOR TO CALLING THEY'D CALLED AND EMAILED THEIR HEALTHCARE PROVIDER (HCP) AND HAVE NOT GOT A RESPONSE BACK. PATIENT STATED THE INS ON THE LEFT SIDE WAS AT 100% (AGENT NOT SURE WHAT THE PATIENT WAS REFERRING TO GIVEN THAT THE INS IS A NON-RECHARGEABLE), AND THEY WERE UNABLE TO CHECK THE RIGHT INS. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. THE SERIAL NUMBER OF THE PP WAS NOT COLLECTED DUE TO PATIENT UNABLE TO OPEN BATTERY COMPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 18630958 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHAKING ALL OVER. PATIENT INITIALLY MENTIONED MONDAY WHEN AGENT ASKED FOR THE EVENT DATE AND PATIENT ALSO MENTIONED "WAKING UP WITH THIS" TODAY. PATIENT WANTED TO CHECK THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE THE PATIENT PROGRAMMER (PP) BUT WAS UNABLE TO DO SO BECAUSE THE PP WOULDN'T POWER ON.  PATIENT TRIED TO REPLACE BATTERIES BUT COULDN'T BECAUSE THE BATTERY COMPARTMENT DOOR WAS STUCK AND WOULDN'T OPEN. PATIENT STATED PRIOR TO CALLING THEY'D CALLED AND EMAILED THEIR HEALTHCARE PROVIDER (HCP) AND HAVE NOT GOT A RESPONSE BACK. PATIENT STATED THE INS ON THE LEFT SIDE WAS AT 100% (AGENT NOT SURE WHAT THE PATIENT WAS REFERRING TO GIVEN THAT THE INS IS A NON-RECHARGEABLE), AND THEY WERE UNABLE TO CHECK THE RIGHT INS. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. THE SERIAL NUMBER OF THE PP WAS NOT COLLECTED DUE TO PATIENT UNABLE TO OPEN BATTERY COMPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 18630456 ↗
• MalfunctionJan 31, 2024Impedance Problem; Impedance Problem

  FURTHER REVIEW INDICATED THE EVENT WAS REPORTED IN ERROR. IMPEDANCE WAS 265 OHMS WHICH WAS IN THE THRESHOLD FOR THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613585 ↗
• 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. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608780 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Insufficient Device Problem Information; Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT THAT THE PATIENT PROGRAMMER HAS BEEN SPORADIC FOR A COUPLE WEEKS AND NOW WOULD NOT POWER ON AT ALL.  PATIENT HAS TRIED TWO NEW SETS OF BATTERIES AND THAT DID NOT RESOLVE THE ISSUE. A REPLACEMENT PROGRAMMER WAS SENT OUT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607222 ↗
• MalfunctionJan 11, 2024Failure to Power Up; Insufficient Device Problem Information; Failure to Power Up; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS CALLER STATES THE PATIENT PROGRAMMER IS NOT WORKING. CALLER STATES THEY WERE AT THE HEALTHCARE PROVIDER YESTERDAY AND THE IMPLANTED NEUROSTIMULATOR WAS CHECKED WITH A SEPARATE DEVICE AND IT IS WORKING FINE BUT WHEN THEY TRIED TO USE THE PROGRAMMER IT WAS NOT TURNING ON AND REPLACING THE BATTERIES DID NOT RESOLVE THE ISSUE. THE CALLER CONFIRMED THAT THEY WERE USING REGULAR BATTERIES. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE 37642 DEVICE. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491956 ↗
• InjuryAug 22, 2023Premature Discharge of Battery; Migration or Expulsion of Device; Insufficient Device Problem Information; Premature Discharge of Battery; Migration or Expulsion of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY DIDN¿T KNOW WHAT LED TO THE POCKET EROSION OR LONGEVITY ISSUE AS WITHIN WEEKS IT LOOKED LIKE SOMEONE TOOK A CIGARETTE AND BURNED THE PATIENT. THE DEFECTIVE INS WAS REMOVED AND REPLACED WITH A NEW INS WHICH RESOLVED THE ISSUE.

  Patient problems: Insufficient Information; Pocket Erosion

  MAUDE report 17599502 ↗
• MalfunctionJul 27, 2023Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) THAT THE NEW IMPLANTABLE NEUROSTIMULATOR (INS) IS OVERSENSING STIMULATION OUTPUT. REP WAS TRANSFERRED FROM CARDIO TO NEURO STIM TECHNICAL SERVICES (TS) TO SEE IF THE INS COULD BE TURNED OFF. IT WAS REPORTED THAT THE PATIENT'S CARDIAC DEVICE WAS REPLACED AND THE NEW PACEMAKER IS OVERSENSING THE DBS STIMULATION PULSES. THE CALLER WAS TRANSFERRED FROM CARDIAC TECH SERVICE AND THEY INDICATED THAT IT WAS UNKNOWN IF THE PATIENT WAS ALSO EXPERIENCING AFIB. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THE INTERFERENCE WAS NOT CONFIRMED AS THERE ARE NO PATIENT SYMPTOMS. THERE IS A POSSIBILITY OF AFIB. NO INTERVENTION WAS NEEDED. FURTHER INVESTIGATION WILL OCCUR AT FOLLOW-UP. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY HAD NO FURTHER INFORMATION ON THE PATIENT¿S MEDICAL HISTORY. THE PATIENT WAS PRESENT FOR A GENEXCHANGE AND HIS NS WAS ON AND HAS BEEN ON FOR YEARS ACCORDING TO THE PATIENT¿S FAMILY. HE HAS AN ATRIAL ONLY PACER AND IT MAY BE SENSING HIS AFIB. BOTH OF THE PATIENT¿S SYSTEMS ARE CHRONIC SYSTEMS AND THERE WAS CONFIRMATION IF THIS WAS INTERFERENCE BASED ON LIMITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406432 ↗
• InjuryJul 7, 2023Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED PATIENT NOTICED RETURN OF SYMPTOMS, TREMORS, ABOUT 2 WEEKS AGO. HE HAD NOTED SHOCKING SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THEN THE INS DIED. PATIENT CHECKED AND STIM WAS OFF AND ERI HAD TRIGGERED AT SOME POINT. INS BATTERY LEVEL IS SHOWING 2.9V TODAY. CALLER NOTED THE PATIENT IS PROGRAMMED TO C1 3.4 60PW RATE 150 AND UNABLE TO TAKE IMPEDANCES. PREVIOUS SHOWED C1 318OHMS, C2 405OHMS, C2 1100+ C3 1100+LONGEVITY SHOWED 2+YEARS ESTIMATE. CALLER WILL DISCUSS WITH SURGEON AND NOTED IMPEDANCES AFTER REPLACING INS TODAY. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE DATE OF REPLACEMENT WAS JUNE 26, 2023. THE PATIENT¿S IMPEDANCE ISSUES WERE: MONOPOLAR 1 249 OHMS, 0 230 OHMS AND BIPOLAR 0 1 144 OHMS. FOLLOWING REPLACEMENT, THE SHOCKING SENSATIONS RESOLVED.

  Patient problems: Electric Shock; Shaking/Tremors

  MAUDE report 17279543 ↗
• MalfunctionJun 28, 2023High impedance; Low impedance; High 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 SHORT AND HIGH IMPEDANCE WASN¿T DETERMINED AS IT HAD BEEN THERE FOR ¿SOME TIME,¿ BUT THEY WEREN¿T TOLD WHEN IT STARTED EXACTLY. THE ISSUE WASN¿T RESOLVED BUT THE PATIENT WAS ASYMPTOMATIC AND MOST LIKELY WOULDN¿T BE GETTING A REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219180 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ALLIED HEALTHCARE PROVIDER THAT THE PATIENT WAS HOSPITALIZED WITH AND WITHOUT TONIC-CLONIC SEIZURE ACTIVITY. THE PATIENT HAD GARBLED SPEECH AND WAS NOT RESPONDING WELL. THE PATIENT HAD TBI (TRAUMATIC BRAIN INJURY) WHEN THEY WERE A CHILD.

  Patient problems: Convulsion/Seizure; Dysphasia; Insufficient Information

  MAUDE report 17056335 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET. THE PATIENT ALSO HAS BEDSORES AND IS IN A NURSING HOME. THE EXTENSION WAS CUT AND ANTIBIOTICS WERE APPLIED. THE PATIENT PREVIOUSLY HAD SKIN EROSION AT THE POCKET, AND A CULTURE DETERMINE AN INFECTION WAS PRESENT. THE PHYSICIAN CUT THE LEAD AND PROVIDED ANTIBIOTICS.

  Patient problems: Erosion; Pressure Sore/Ulcer; Unspecified Infection

  MAUDE report 16987818 ↗
• InjuryMar 28, 2023Low impedance; Battery Problem; Low impedance; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE LOW IMPEDANCE WASN¿T DETERMINED AND THE ISSUE WASN¿T RESOLVED. THE DEVICE WAS CURRENTLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627899 ↗
• MalfunctionFeb 20, 2023Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT ELECTROMAGNETISM FROM MOTORIZED BED THAT PATIENT (PT) STATED WAS VERY OLD AT NURSING HOME SHE IS IN. PT REPORTED FEELING LIKE SHE GOT MAGNETS OR CURRENT GOING THROUGH HER LEFT LEG. FEET ARE FEELING BOUND DOWN TO THE DUE TO THE MAGNETIC FIELD PULL ON HER FEET WHICH PREVENTS HER FROM MOVING HER FEET. SHE REPORTED THIS STARTED 5 WKS AGO WHEN SHE GOT A NEW MATTRESS FOR MORE CUSHION. CALLER STATED PEOPLE AT NURSING HOME ARE NOT BELIEVING HER. THERE WAS NO COMPLAINT ABOUT DBS THERAPY OR DEVICE ISSUES TODAY. REDIRECTED PATIENT TO HEALTHCARE PROVIDER (HCP).

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16404250 ↗

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.