ACTIVA® SC 37602 (UDI 00613994761064)Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00613994761064), received between May 4, 2017 and May 6, 2024 — classified as 2 deaths, 74 injuries, 121 malfunctions.

The most frequently reported specific device problem is “High impedance” (38 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (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 197 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CALLER WAS A HEALTHCARE PROVIDER AND THE REASON FOR THE CALL WAS TO GET DEVICE REGISTRATION INFORMATION. THE CALLER REPORTED THAT THE PATIENT HAD A LEAD REVISION OF THE LEFT SIDE LEAD. THE CALLER INDICATED THAT THE PATIENT WAS NOT GETTING EFFECTIVE TREMOR RELIEF SOMETIME BETWEEN PLACEMENT IN 2011 AND 2014. THEY ADDED A SECOND RIGHT SIDE LEAD AND THE CALLER THINKS THAT THE FIRST RIGHT SIDE REMAINED IMPLANTED BECAUSE IT PROVIDE SOME THERAPEUTIC EFFECT. THE CALLER DID NOT HAVE OTHER DETAILS ABOUT THE STATUS OF THE THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 19250409 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  ON 2022-MAR-15 RTG0281019, RPL 335599 (CON): IT WAS REPORTED THAT THE PROGRAMMER WOULDN¿T POWER ON EVEN AFTER TWO NEW SETS OF BATTERIES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611278 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER WOULDN¿T POWER ON EVEN AFTER TWO NEW SETS OF BATTERIES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611273 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED THE PROGRAMMER WASN¿T POWERING ON EVEN AFTER THE BATTERIES WERE REPLACED. IT WAS CONFIRMED THERE WAS NO CORROSION IN THE BATTERY COMPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607867 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PATIENT PROGRAMMER WOULD NOT POWER ON. THE PATIENT STATED THAT THEY REPLACED THE AAA BATTERIES IN THE PATIENT PROGRAMMER, BUT THE ISSUE PERSISTED. THE PATIENT CONFIRMED THEY WERE USING ALKALINE BATTERIES. THE PATIENT DENIED DROPPING THE PATIENT PROGRAMMER OR GETTING IT WET. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED AS THE PATIENT DID NOT HAVE THE PATIENT PROGRAMMER WITH THEM. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607140 ↗
• MalfunctionNov 15, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THERE WERE LOW IMPEDANCES AT THE 2/3 COMBINATION, BOTH IN PRE-OP WITH THE EXPLANTED IMPLANTABLE NEUROSTIMULATOR (INS) AND INTRA-OP WITH THE NEW INS. THE SURGEON WAS UNCONCERNED, SINCE THE LOW IMPEDANCES PRESENTED IN PRE-OP ON AN OLD (15 YEARS OLD) SYSTEM WITH NO DETRIMENTAL EFFECTS ON THERAPY, WERE ON AN UNUSED CONTACT COMBINATION, AND DID NOT PRESENT ON THE INDIVIDUAL CONTACTS WHEN TESTED IN MONOPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140911 ↗
• InjuryAug 22, 2023Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY DIDN'T KNOW WHAT LED TO THE LONGEVITY ISSUE. THE DEFECTIVE INS WAS REMOVED AND REPLACED WITH A NEW INS WHICH RESOLVED THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 17599557 ↗
• InjuryJul 21, 2023Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED THAT ON (B)(6) 2023 THEY NOTICED THEY WERE GETTING MINOR TREMORS ON THE LEFT SIDE OF THEIR BODY. WHEN THE PATIENT CHECKED THE RIGHT INS (B)(6) WITH THEIR PATIENT PROGRAMMER, THEY SAW A SCREEN THAT THEY THOUGHT MEANT THE INS BATTERY STOPPED WORKING AND NEEDED TO BE REPLACED. AGENT ASKED THE PATIENT IF THEY SAW THE EOS SCREEN WHEN THEY CHECKED THE RIGHT INS, BUT THEY DO NOT REMEMBER SEEING THE EOS SCREEN. THE PATIENT ALSO MENTIONED THAT THEY PASSED OUT IN CHURCH YESTERDAY, BUT THEY WEREN'T SURE IF THAT WAS RELATED TO THE DBS SYSTEM. REGARDING WHEN THEY PASSED OUT IN CHURCH YESTERDAY, THE PATIENT STATED, "MY LEFT SIDE FELT REAL WEAK AND DOWN I WENT." DURING THE CALL, THE PATIENT KEPT SEEING THE 'POOR COMMUNICATION' SCREEN WHEN THEY CHECKED THE RIGHT INS. HOWEVER, SYNCHRONIZATION WAS SUCCESSFUL WITH THE LEFT INS (B)(6). FOR THE LEFT INS, THE PATIENT PROGRAMMER INDICATED THAT THERAPY WAS ON AND THE INS BATTERY LEVEL WAS OK. THE PATIENT TRIED TO CONNECT TO THE RIGHT INS AGAIN, BUT THEY CONTINUED TO SEE THE 'POOR COMMUNICATION' SCREEN. THE PATIENT MENTIONED THAT THEY WERE SUPPOSED

  Patient problems: Loss of consciousness; Muscle Weakness/Atrophy; Shaking/Tremors

  MAUDE report 17375157 ↗
• MalfunctionJul 16, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THE SHOCKING WAS THE DEVICE BEING TURNED ON. THE SHOCKS HAD BEEN GOING ON SINCE IMPLANT. THE PATIENT ONLY EXPERIENCED SHOCKS ON THEIR RIGHT SIDE AND IT MADE THEIR LEGS JUMP WHICH HAPPENED EVERY TIME SINCE THEIR NEUROLOGIST TURNED ON THE DEVICE TO ADJUST THE BATTERY. THE SHOCKING RESOLVED AFTER A FEW SECONDS AND THUS NO FURTHER ACTION WAS TAKEN.

  Patient problems: Electric Shock

  MAUDE report 17330911 ↗
• MalfunctionJul 16, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THEY GET A SHOCK WHENEVER THE IMPLANTABLE NEUROSTIMULATOR (INS) GETS TURNED ON OR OFF. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. THE PATIENT STATED THAT THEY HAVE EXPERIENCED THIS WITH EVERY INS THEY HAVE HAD IMPLANTED, WHICH DATES BACK TO 2003. THE PATIENT STATED THAT THEIR HEALTHCARE PROVIDER (HCP) HAS WITNESSED THE SHOCK THEY GET WHEN THEY ARE AT APPOINTMENTS GETTING THE INS CHECKED OR IF THE HCP "CHANGES THE VOLTAGE OR WHATEVER." THE PATIENT MENTIONED THAT THEY GOT THE SHOCK THIS MORNING WHEN THEY TURNED THE INS OFF (THEY DID NOT SPECIFY WHICH INS THEY TURNED OFF). THE PATIENT STATED THAT THE SHOCK ONLY LASTS A COUPLE OF SECONDS. THE PATIENT STATED THAT THE SHOCK STARTS AT THE FINGER TIPS OF THEIR RIGHT HAND, THEN IT GOES ALL THE WAY UP THEIR ARM AND COMES OUT THE TIP OF THEIR TONGUE. THE PATIENT STATED THAT THEIR HCP IS AWARE OF THE ISSUE, AND THEY JUST WARN THE PATIENT THAT THEY ARE GOING TO GET THE SHOCK DURING APPOINTMENTS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. REFER TO MANUFACTURER'S REPORT 1030489-2023-00513, 3004209178-2023-12701, 3004209178-2023-12702, AND 1030489-2023-0

  Patient problems: Electric Shock

  MAUDE report 17330910 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT IMPLANTABLE NEUROSTIMULATOR (INS) (B)(6) DOES NOT WORK. THE PATIENT EXPLAINED THAT BOTH OF THEIR HANDS WERE SHAKING, SO 2-3 YEARS AGO THEIR HEALTHCARE PROVIDER (HCP) MOVED BOTH IMPLANTED WIRES TO THE RIGHT FOR THE RECHARGEABLE INS (B)(6), AND THEY DISCONNECTED THE LEFT INS. THE LEFT INS IS STILL IMPLANTED. AFTER THE IMPLANTED WIRES WERE MOVED, THE PATIENT STATED THAT IT HELPED THEIR SHAKING A LITTLE BIT. THE PATIENT STATED THAT THEY CAN MOVE THEIR RIGHT HAND PRETTY WELL, BUT THEY CANNOT WITH THEIR LEFT HAND, AND THEY CAN DO MOST EVERYTHING THEY NEED TO WITH THEIR RIGHT HAND. THE PATIENT STATED THAT THEIR HANDS STILL SHAKE BUT THEY DO PRETTY WELL. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. THE PATIENT WAS REDIRECTED TO THEIR HCP TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE PATIENT WAS SCHEDULED FOR A ROUTINE LEFT ERI INS REPLACEMENT ON (B)(6) 2023. PATIENT RECEIVED A NEW INS AT THAT TIME. IT IS UNKNOWN IF THIS EVENT IS RELATED TO A PREVIOUSLY REPORTED EVENT AS THE PATIENT HAS COGNITIVE DECLINE AND IS NOT ABLE TO ACCURATELY STATE HISTORICAL E

  Patient problems: Cognitive Changes; Shaking/Tremors

  MAUDE report 17153928 ↗
• MalfunctionJun 12, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE PATIENT WAS TOLD TO FOLLOW-UP WITH THEIR PHYSICIAN REGARDING THE CAUSE THE SHOCK, ACTIONS TAKEN, AND IF IT RESOLVED, SO NO FURTHER INFORMATION WAS AVAILABLE AT THIS POINT.

  Patient problems: Electric Shock; Muscular Rigidity

  MAUDE report 17112903 ↗
• InjurySep 22, 2022High impedance; Battery Problem; High impedance; Battery Problem

  IT WAS REPORTED THAT ONE INS IS ERI AND THAT DEVICE IS GOING TO BE REPLACED. CALLER STATES SHE INTERROGATED PATIENT (PT) TODAY IN PREPARATION FOR REPLACEMENT AND NOTICED ONE MONOPOLAR CONTACT PAIR IS SHOWING 'HIGH'. TECHNICAL SERVICES (TSS) AND CALLER REVIEWED AVOIDING THAT CONTACT. 2.0V 130HZ 60USEC 846OHMS 24-7ERI 6.3 YEARS EOS 6.5 YEARS. CURRENT BATTERY VOLTAGE 2.96. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) THAT THEY DID NOT HAVE THE SERIAL NUMBER OF THE INS WITH THE IMPEDANCE ISSUE/BEING REPLACED. HCP STATES THEY HAVE NOT SEEN THE PATIENT SINCE (B)(6) 2021, THERE WAS NO IMPEDANCE ISSUE AT THAT TIME. IN RESPONSE TO QUESTION IF ERI WAS CAUSED BY NORMAL BATTERY DEPLETION, HCP REPORTS THEY SUSPECT A DEVICE ISSUE AS PATIENT'S BATTERY LEVEL WAS 2.97 FOR LEFT, 2.8 FOR RIGHT ON (B)(6) 2021. IT WAS NOT SPECIFIED WHICH INS WAS REPLACED. REFER TO MANUFACTURER REPORT 3004209178-2022-12217 FOR RELATED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465261 ↗
• InjuryAug 25, 2022Migration or Expulsion of Device; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S (PT) DAUGHTER IS CONCERNED ABOUT FALL TO LEFT SIDE OF HEAD/BODY THAT MAY HAVE CAUSED A SYSTEM INTEGRITY ISSUE. PT HIT LEFT SIDE TEMPLE. DAUGHTER MENTIONED ALSO THE LEFT INS WAS IN LOWER PART OF CHEST BEFORE FALL, AND NOW IT APPEARS TO HAVE SHIFTED UP TOWARD SHOULDER MORE. REP WILL BE AT THE SCHEDULED (NOT CONFIRMED) BATTERY CHANGES (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292984 ↗
• InjuryAug 22, 2022Impedance Problem; Patient Device Interaction Problem; Impedance Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT SAW OOR MESSAGES FROM THE HANDSET WITH TWO DIFFERENT CODES- 1703 AND 1098. TECHNICAL SERVICES REVIEWED OOR INFORMATION WITH THE CALLER. THE PATIENT STATED ABOUT A YEAR AGO STARTING TO HAVE IMPEDANCE ISSUES AND HAD A PROCEDURE DONE WHERE THEY UNPLUGGED THE LEAD /EXTENSION AND PLUGGED IT IN AGAIN. IMPEDANCE WAS BETTER BUT NOT 100%. THEN ABOUT 4 MONTHS AGO, THE PATIENT HAD BATTERY CHANGE TO PERCEPT AND HAD EXTENSION REPLACED AND STILL THERE IS A CONSTANT IMPEDANCE ISSUE AND IT COMES AND GOES. THE PATIENT DOES NOT THINK THE IMPLANTABLE NEUROSTIMULATOR (INS) DIED BECAUSE OF IMPEDANCE ISSUE BUT DUE TO REGULAR LONGEVITY. THE PATIENT WENT FROM HAVING 2 INS'S TO ONE INS. THE PATIENT STATED THE SURGEON NOTICED THERE WAS A DIFFERENCE WHEN THE PATIENT WAS TURNING THEIR HEAD IN A CERTAIN DIRECTION AND DETERMINED THE LEAD IS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271338 ↗
• MalfunctionJul 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT UPON ROUTINE ELECTIVE REPLACEMENT (ERI) FOR BOTH IMPLANTED NEUROSTIMULATORS (INS), IMPEDANCE TESTS SHOWED ABNORMAL RESULTS FOR EACH OF THE TWO SINGE CELL NEUROSTIMULATORS. RIGHT IMPLANT SHOWED CONTACT 3 WAS "HIGH" ON ALL PAIRS --NO VALUE SHOWED., MONOPOLAR AND 0 HIGH 6,564; 0 AND 1 5747 AND 0 AND 6,946. LEFT IMPLANT CONTACT MONOPOLAR SHOWED 0 2,536 OHM; CONTACT 3 HIGH ON ALL PAIRS- NO VALUE WAS GIVEN.  AFTER REPLACEMENT, IMPEDANCE TESTS FOR THE UPGRADED IMPLANTS SHOWED NO "HIGH/SHORTS" NOW; NO MORE RED VALUES. FURTHERMORE, THE PROVIDER PROGRAMMED THE PATIENT SO AS TO NOT USE ANY OF THE CONTACTS THAT HAD IMPEDANCE ISSUES. EVENT IS RESOLVED AT TIME OF REPORT. CAUSE WAS UNKNOWN. REFER TO MANUFACTURER REPORT 3004209178-2022-08749 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982220 ↗
• MalfunctionJul 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT UPON ROUTINE ELECTIVE REPLACEMENT (ERI) FOR BOTH IMPLANTED NEUROSTIMULATORS (INS), IMPEDANCE TESTS SHOWED ABNORMAL RESULTS FOR EACH OF THE TWO SINGE CELL INSES. RIGHT IMPLANT SHOWED CONTACT 3 WAS "HIGH" ON ALL PAIRS --NO VALUE SHOWED., MONOPOLAR AND 0 HIGH 6,564; 0 AND 1 5747 AND 0 AND 6,946. LEFT IMPLANT CONTACT MONOPOLAR SHOWED 0 2,536 OHM; CONTACT 3 HIGH ON ALL PAIRS- NO VALUE WAS GIVEN.  AFTER REPLACEMENT, IMPEDANCE TESTS FOR THE UPGRADES IMPLANTS SNOWED  NO "HIGH/SHORTS" NOW; NO MORE RED VALUES. FURTHERMORE, THE PROVIDER PROGRAMMED THE PATIENT SO AS TO NOT USE ANY OF THE CONTACTS THAT HAD IMPEDANCE ISSUES. EVENT IS RESOLVED AT TIME OF REPORT. CAUSE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982126 ↗
• InjuryMay 10, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S (PT) LEFT BATTERY WAS IN ERI STATUS AND WAS SCHEDULED FOR ELECTIVE BATTERY REPLACEMENT. SHE BEGAN TO DECLINE RAPIDLY AND BECAME ESSENTIALLY BEDRIDDEN WITH DECREASED ORAL INTAKE. AS SUCH, REPLACEMENT WAS ARRANGED ON A MORE URGENT BASIS.

  Patient problems: Insufficient Information

  MAUDE report 14349082 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DESCRIBED THE PATIENT'S MENTAL STATUS AS CONFUSED. THE CALLER STATED THAT THEY THOUGHT THE PATIENT'S MENTAL STATUS WAS RELATED TO THE PATIENT'S PARKINSON'S AND DEMENTIA GETTING WORSE. WHEN THE PATIENT WAS ORIGINALLY ADMITTED TO THE HOSPITAL THEY HAD SYMPTOMS THAT INCLUDED BEING DISORIENTED, HALLUCINATING, "NOT WITH IT", AND NOT FOLLOWING COMMANDS. THE CALLER INDICATED THAT AT THE TIME OF THE CALL THESE SYMPTOMS RESOLVED OR IMPROVED SINCE THE ADMISSION TO THE HOSPITAL.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Dementia

  MAUDE report 14329143 ↗
• MalfunctionApr 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER, VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED THE LEFT EXTENSION WAS PLANNED TO BE REMOVED AND REPLACED WITH A DIFFERENT EXTENSION TO ALLOW FOR A FULL BODY MRI AN TO ALLEVIATE THE NEED FOR A POCKET ADAPTER WHEN IMPLANTING A RECHARGEABLE NEUROSTIMULATOR (REPLACING A PRIMARY CELL) ON THE LEFT SIDE. DURING THE REMOVAL OF THE EXTENSION, THE SURGEON NOTICED THE WIRES WERE EXPOSED WHEN PULLING THE EXTENSION OUT AS THE OUTER COATING OF THE EXTENSION WIRE APPEARED TO SHRED OFF OF THE WIRES LEAVING THEM EXPOSED. THE EXTENSION WAS REMOVED AND REPLACED AND CONNECTED TO THE NEW RECHARGEABLE NEUROSTIMULATOR AND EXISTING RIGHT SIDED LEAD WITH ALL IMPEDANCES NORMAL AND THE ISSUE BEING RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250865 ↗
• MalfunctionApr 12, 2022Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  IT WAS REPORTED THAT THE CALLER INDICATED THAT THE PATIENT'S WIFE THINKS THAT THE IMPLANTED DEVICE IS GOING DEAD. WHEN THEY CHECKED THE INS YESTERDAY, THE THERAPY WAS OFF AND THE WIFE TURNED THERAPY BACK ON AND THAT CAUSED THE PATIENT TO BE JOLTED. THE CALLER LATER DESCRIBED THE SEQUENCE OF EVENTS AS THE WIFE TURNED THERAPY ON AND THEN THE PATIENT WOKE UP WITHIN A FEW MINUTES. THE AGENT ASKED FOR CLARIFICATION IF THE PATIENT WAS JOLTED OR IF THE PATIENT JUST WOKE UP AND THE CALLER STATED THAT THE PATIENT'S WIFE DESCRIBED THE SCENARIO BOTH WAYS AND COULD NOT CLARIFY. THE CALLER STATED THAT THE PATIENT'S WIFE NEVER NOTICED THAT THE THERAPY WAS TURNED OFF BEFORE AND THEY DIDN'T SEEM TO KNOW HOW STIM WAS OFF. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: Electric Shock

  MAUDE report 14084113 ↗
• MalfunctionMar 30, 2022High impedance; High impedance

  IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) CALLED TODAY TO ASK FURTHER QUESTIONS REGARDING OPTIONS FOR ISSUE WITH HIGH IMPEDANCES ON CONTACT 0 THAT CAN'T BE RESOLVED. CALLER INDICATED HE IS NOT AT THE CASE BUT IS ASSISTING THE REPS AT THE CASE. THEY CHANGED OUT THE OLD STYLE (DUCKBILL) EXTENSION FOR NEW EXTENSION TO CONVERT PATIENT TO NEW INS. UPON TESTING WITH NEW EXTENSION, CONTACT 0 IS SHOWING HIGH. TOTAL OF 3 EXTENSIONS TRIED WITH INS AND CONTACT 0 STILL SHOWED HIGH, LEAD WAS WIPED DOWN. LEAD TESTED FINE IN OPERATING ROOM, IMPEDANCES TESTED FINE PRIOR TO REMOVING THE PREVIOUS INS. NO PATIENT INFORMATION WAS AVAILABLE AT THE TIME OF THIS CALL. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE NORMAL IMPEDANCE PRE-OPERATION. THE NEW EXTENSION AND PERCEPT HAD HIGH IMPEDANCES (OVER 5K MONO AND 10K ALL BIPOLE). RECONNECTED AND CHANGED PORTS WITH NO CHANGE. TWIST LOCK ON LEAD HAD NORMAL IMPEDANCE. THE SECOND PERCEPT HAD HIGH IMPEDANCE. THE 37603 HAD HIGH IMPEDANCE. TOTAL OF 3 EXTENSIONS USED SHOWED HIGH IMPEDANCE. NORMAL IMPEDANCES ONLY OCCURRED WHEN THE HCP RAN SALINE OVER THE LEAD/EXTENSION CONNECTION. THE LEAD WAS NOT ACTIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955517 ↗
• InjuryMar 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BOTH IMPLANT BATTERIES REPLACED WITH PERCEPT DEVICES. THE PATIENT SAID THEY THINK THEY ALSO HAD A LEAD REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841447 ↗
• MalfunctionDec 3, 2021High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT PATIENT HAS A BILATERAL INS CHANGE DUE TO EOS/ERI. THE FOLLOWING INFORMATION WAS RECEIVED: LEFT SC SHOWED SHORT CIRCUIT/LOW IMPED AT PREOP INTERROGATION FOR ERI BATTERY CHANGE ON MONOPOLAR C AND 0 VALUE 224 OHM. MONOPOLAR CASE AND 1 SHOWED SLIGHTLY HIGH AT 2623. AFTER CONNECTED NEW SC IMPED ISSUE AT CONTACT 0 CLEARED (VALUE 304 OHMS) BUT CONTACT ONE IN BOTH MONOPOLAR AND BIPOLAR CONFIGS ARE ALL HIGH AT 12,9K MONOPOLAR AND BOTH AT 13,6K BIPOLAR.  RT SC WAS AT EOS COULD NOT RUN ANY IMPED TEST IN PREOP. AFTER CONNECTING NEW SC SEE IMPED ISSUE AT C AND 0 OF 2979. HCP WAS ABLE TO PROGRAM AROUND THAT CONTACT AND RERAN IT A FEW TIMES. THE ISSUE HAS BEEN RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929379 ↗
• InjuryNov 2, 2021Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THE LONGEVITY ISSUE WAS IT ¿SHOCKING THEM.¿ THE DEVICE WAS DISCARDED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.