Activa® PC 37601 (UDI 00643169864191)Recalls & reported problems

Summary

The FDA's MAUDE database contains 502 adverse event reports that list this exact device (DI 00643169864191), received between Apr 13, 2018 and Jan 27, 2026 — classified as 1 death, 233 injuries, 268 malfunctions.

The most frequently reported specific device problem is “High impedance” (95 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 502 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Overheating of Device

  IT WAS REPORTED THAT PATIENT MENTIONED THEY FELT A LITTLE TINGLING AND A BURN IN THE AREA OF THE IMPLANT. PATIENT SAID THEY HAD EXPERIENCED THIS OFF AND ON THROUGHOUT THE YEARS AND THERE WAS NO RHYME OR REASON, SOMETIMES IT WAS STRONG AND SOMETIMES IT WASN'T. PATIENT STATED THERE WERE SOME EVENINGS THEY WOULD SIT WATCHING TV AND TELL THEIR HUSBAND IT FELT LIKE IT WAS BURNING. AGENT CONFIRMED THIS HAS BEEN ONGOING SINCE HER FIRST IMPLANT BACK IN 2018. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Burning Sensation; Paresthesia

  MAUDE report 24192050 ↗
• MalfunctionJan 2, 2026Energy Output Problem

  IT WAS REPORTED THAT THE REASON FOR CALL WAS TO REVIEW SOME DEVICE EDUCATION. DURING THE CALL, PATIENT REPORTED A HISTORICAL EVENT, SAYING THAT THE FIRST TIME THEY GOT THE IMPLANTABLE NEUROSTIMULATOR (INS) EVERYTHING WAS PERFECT FOR ABOUT 6 MONTHS AND THEN AFTER THAT THEY COULDN'T GET BACK TO A GOOD SPOT. PATIENT SAID THEY SPENT TWO YEARS WITH THE DOCTOR MAKING ADJUSTMENTS AND THEN TOGETHER THEY MADE THE DECISION TO LEAVE AT THE BEST THEY COULD GET IT TO, THOUGH IT NEVER WENT BACK TO HOW IT WAS THOSE FIRST SIX MONTHS. PATIENT SAID WHEN THEY GOT THE BATTERY REPLACED THREE YEARS LATER THEY DIDN'T DO ANY ADJUSTMENTS AND JUST LEFT THE THERAPY WHERE IT WAS BUT NOW WITH THE LATEST REPLACEMENT, THEY HAVE AN APPOINTMENT ON THE 22ND WITH A NEW NEUROLOGIST WHO IS GOING TO RECALIBRATE THEIR BATTERY. THIS NEW DOCTOR IS GOING TO WORK WITH PATIENT'S CURRENT DOCTOR AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944193 ↗
• MalfunctionAug 20, 2025Failure to Deliver Energy; Low impedance; Battery Problem; Failure to Deliver Energy; Low impedance; Battery Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ACTIVA PC IMPLANTABLE PULSE GENERATOR PRESENTED TO THE HOSPITAL WITH OFF STIMULATION, AND A CHARGE DENSITY EXCEED WARNING WAS IDENTIFIED. WHEN AN IMPEDANCE TEST WAS PERFORMED AT 3V, THERE WAS NO THERAPY IMPEDANCE RESULT BECAUSE THE IMPLANTABLE PULSE GENERATOR WAS OFF. AN IMPEDANCE TEST AT 0.7V PRODUCED A THERAPY IMPEDANCE RESULT, ALLOWING DETERMINATION OF THE TRUE CHARGE DENSITY THRESHOLD. LOW IMPEDANCES WERE DISCOVERED ON CONTACTS 2 AND 8, WHICH WERE AVOIDED. TECHNICAL SERVICE WAS CONSULTED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854819 ↗
• MalfunctionAug 20, 2025Failure to Interrogate; Energy Output Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Failure to Interrogate; Energy Output Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ACTIVA DEEP BRAIN STIMULATION IMPLANT FOR MS TREMOR EXPERIENCED ATAXIA SIDE EFFECTS WHEN THE DEVICE WAS ON AND WAS UNABLE TO TURN THE DEVICE OFF AFTER COOKING ON AN INDUCTION STOVE, WITH THE DEVICE REMAINING ON FOR 24-48 HOURS BEFORE RESETTING. THE PATIENT PROGRAMMER STOPPED CONNECTING TO THE IMPLANTABLE PULSE GENERATOR (IPG) DURING OR AFTER USE OF THE INDUCTION STOVE, AND THE PATIENT WAS ONLY ABLE TO KEEP THE DEVICE ON FOR AN HOUR AT A TIME DUE TO ATAXIA SIDE EFFECTS, PRIMARILY USING IT FOR COOKING. DEVICE INTERROGATION WAS PERFORMED AND RESULTS APPEARED NORMAL. TROUBLESHOOTING STEPS INCLUDED HAVING THE PATIENT USE THE REMOTE AWAY FROM THE INDUCTION STOVE AND TURNING OFF THE COMMUNICATOR DEVICE IMMEDIATELY AFTER USE. THE PHYSICIAN CONTACTED ENGINEERS TO INVESTIGATE POSSIBLE FREQUENCY INTERFERENCE BETWEEN THE INDUCTION STOVE AND THE COMMUNICATOR, AND THESE STEPS WERE BEING TRIED AS INITIAL MEASURES. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22849205 ↗
• InjuryJun 17, 2025Break; Low impedance; Break; Low impedance

  IT WAS REPORTED THAT WHILE THE PATIENT WAS GETTING ANOTHER MANUFACTURER DBS SYSTEM REPLACED, THEY DECIDED TO GET THEIR OTHER DBS SYSTEM REPLACED AS WELL. DURING THE PROCEDURE DEVICE INTERROGATION SHOWED LOW IMPEDANCES ON THE RIGHT SIDE AND ADDITIONAL TESTING SHOWED THE EXTENSION WAS MALFUNCTIONING, SO IT WAS REPLACED. THE ISSUE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2025.

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

  MAUDE report 22235288 ↗
• MalfunctionMay 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE REPRESENTATIVE ENCOUNTERED A POR MESSAGE EACH TIME THEY ATTEMPTED TO RUN THERAPY IMPEDANCE WITH THE PATIENT'S IMPLANT. THE REPRESENTATIVE NOTED THAT ELECTRODE IMPEDANCE WAS FINE, AND THE IMPLANT BATTERY VOLTAGE WAS AT 2.4 VOLTS. THE REPRESENTATIVE WAS USING AN OUTDATED CLINICIAN APP VERSION SOFTWARE, AND TECHNICAL SERVICES REVIEWED WITH THE REPRESENTATIVE THAT AN OUTDATED FEATURE INFORMATION CODE COULD CAUSE ISSUES WITH RUNNING THE TEST. ADDITIONALLY, TECHNICAL SERVICES INDICATED THAT THE NEUROSTIMULATOR IS LIKELY AT END OF SERVICE (EOS) BUT HASN'T TAKEN ENOUGH MEASUREMENTS TO DISPLAY THE EOS STATUS. THEY SUGGESTED THE REPRESENTATIVE TRY INTERROGATING THE DEVICE WITH THE CURRENT SOFTWARE VERSION TO SEE IF THAT RESOLVES THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP CONFIRMING THAT THE BATTERY DEPLETION WAS NORMAL OR AS EXPECTED, GIVEN THE SETTINGS. THE CAUSE OF THE POR MESSAGE WAS BELIEVED TO BE ASSOCIATED WITH THE DEVICE APPROACHI NG THE END OF ITS SERVICE (EOS). THE PATIENT'S IMPLANTED NEUROSTIMULATOR WAS REPLACED. THIS WAS A SCHEDULED PROCEDURE. THE ISSUE WAS RESOLVED FOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965003 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE INFECTION WAS FIRST OBSERVED (B)(6) . THE CAUSE OF THE INFECTION WAS NOT DETERMINED. THE ENTIRE SYSTEM WAS EXPLANTED, FLUSHED, AND CLOSED. THE HCP SENT THE DEVICE TO PATHOLOGY.

  Patient problems: Unspecified Infection

  MAUDE report 21455009 ↗
• MalfunctionJan 27, 2025Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED FROM PATIENT. PATIENT CLARIFIED THAT THEY DID NOT FALL OUT OF BED WHEN THEY EXPERIENCED SHOCKING, THAT THEY WERE SITTING IN BED. PATIENT REPORTED THAT CAUSE OF SHOCKING HAS NOT BEEN DETERMINED. PATIENT REPORTED THAT ISSUE OF SHOCKING HAS NOT RESOLVED AND THAT THEY HAVE HAD SHOCKS INTERMITTENTLY SINCE GETTING IMPLANT. PATIENT REPORTED THAT THEY HAVE AN APPOINTMENT TO REPLACE IMPLANT.

  Patient problems: Electric Shock

  MAUDE report 21247752 ↗
• InjuryJan 2, 2025Adverse 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 THE HCP PERFORMED A RESECTION OF THE PATIENT'S EXUBERANT FIBROSIS IN THE NECK IN (B)(6)2020. IT WAS ALSO REPORTED AND IPG CHANGE TO AN ACTIVA PC WITH EXTENSION CABLES IN (B)(6) 2020. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE AND CONFIRMED WITH THE HCP THAT THE BATTERY REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION. THE ISSUE WAS RESOLVED.

  Patient problems: Fibrosis

  MAUDE report 21063812 ↗
• InjuryDec 30, 2024Adverse 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 THE PATIENT HAD A POCKET REVISION RELATED TO BOWSTRINGING IN (B)(6) 2019. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THE PATIENT EXPERIENCED PULLING IN THE NECK. THE ISSUE WAS RESOLVED.

  Patient problems: Neck Stiffness

  MAUDE report 21044035 ↗
• MalfunctionOct 18, 2024High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN I MPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WERE OPEN IMPEDANCES ON CONTACTS 9 AND 11, AS WELL AS AN OOR (OUT OF REGULATION) MESSAGE DISPLAYING. THE ACTIONS/INTERVENTIONS WERE TAKEN. THERE WAS A NEW OPEN CIRCUIT FOUND ON CONTACT 10 AS WELL. THE ONLY MONOPOLAR CONTACT IN RANGE WAS CONTACT 8. THE ISSUE WAS RELATED TO THE DEVICE/THERAPY BUT UNRELATED TO THE IMPLANT PROCEDURE. THE PATIENT HAD A LOSS OF TREMOR CONTROL ON THEIR LEFT HAND DUE TO THE OPEN IMPEDANCES ON CONTACTS 9 AND 11. THE ISSUE WAS ONGOING AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE IMPEDANCE VALUES WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE ISSUE RESOLVE WITHOUT SEQUALAE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20486222 ↗
• MalfunctionAug 27, 2024Overheating of Device; Battery Problem; Electromagnetic Compatibility Problem; Overheating of Device; Battery Problem; Electromagnetic Compatibility Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE ISSUE WAS RESOLVED.

  Patient problems: Burning Sensation

  MAUDE report 20080488 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S FAMILY CALLED TO INFORM THAT RECENTLY, THE PATIENT'S SCALP FELT NUMB AT THE IMPLANTED LEAD LOCATION AND THERE WAS SWELLING AT THE EXTENSION LOCATION. THE DOCTOR DIAGNOSED THAT THERE WAS NO PROBLEM. THE PATIENT IS CURRENTLY PLANNING TO HAVE THE DEVICE EXPLANTED. UNKNOWN IF THE ISSUE IS RESOLVED. THEY WERE ADVISED TO COMMUNICATE WITH HEALTHCARE PROVIDER FOR TREATMENT.

  Patient problems: Numbness; Swelling/ Edema

  MAUDE report 19692257 ↗
• InjuryJul 1, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S INS WAS EXPLANTED DUE TO REACHING END OF LIFE/ERI. THE MEDICAL PROFESSIONAL ALLEGED A DEFICIENCY IN THE DEVICE PERFORMANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649499 ↗
• MalfunctionMar 20, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PATIENT'S PROGRAMMER WILL NOT POWER ON. PATIENT STATES SHE JUST WENT IN FOR A STRESS TEST AND THEY WERE UNABLE TO DO THE TEST BECAUSE PATIENT COULD NOT TURN IMPLANTED NEUROSTIMULATOR OFF. PATIENT TRIED REPLACING THE BATTERIES, BUT THE ISSUE WAS NOT RESOLVED. PATIENT SERVICES EMAILED REPAIR TO REPLACE THE PROGRAMMER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941926 ↗
• MalfunctionMar 19, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) IS IN THE OPERATING ROOM FOR AN EMERGENCY REPLACEMENT OF AN END OF SERVICE (EOS) ACTIVA PC TO PERCEPT. THE MANUFACTURER REPRESENTATIVE (REP) IS UNAWARE OF WHAT THE EMERGENCY WAS BUT ONLY KNOWS THAT DEVICE IS AT EOS. THE HCP COULD NOT GET A THERAPY IMPEDANCE TO PERFORM VOLTAGE TO CURRENT CONVERSION. BOTH ELECTRODE IMPEDANCE AND THERAPY IMPEDANCE WERE RAN, HOWEVER, THERAPY IMPEDANCE ONLY PROVIDED . TECHNICAL SERVICES PERFORMED CONVERSIONS AND SENT THEM IN AN EMAIL. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE DEVICE WAS BELIEVED TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE HCP WAS ABLE TO GET IMPEDANCE NUMBERS, JUST NOT THERAPY IMPEDANCE. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE PHYSICIAN ATTEMPTED TO RUN THERAPY IMPEDANCES MULTIPLE TIMES AND GOT THE MESSAGE. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RESOLVE THE ISSUE WITH NO SUCCESS AND THE ISSUE NOT RESOLVING. NO LOGS WERE AVAILABLE RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933616 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER (HCP) STATED PATIENT'S CURRENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED AND REPLACED WITH BOSTON SCIENTIFIC INS ON (B)(6) 2023 BUT MDT LEADS AND EXTENSIONS REMAIN. TECH SERVICES (TS) REVIEWED MRIS ARE NOT RECOMMENDED FOR MIXED SYSTEMS. HCP STATED PATIENT HAS HAD REVISIONS - ONE WHEN THE INS DIED AND ONE WHEN PATIENT HAD AN INFECTION. HCP BELIEVED REVISIONS OCCURRED IN 2019 AND 2021 BUT COULDN'T CONFIRM WHAT HAPPENED WHEN. TS ASKED FOR FURTHER INFORMATION ABOUT THE INFECTION BUT CALLER WAS ONLY ABLE TO SPECULATE THAT IT WAS AT THE INS SITE.

  Patient problems: Unspecified Infection

  MAUDE report 18915459 ↗
• MalfunctionMar 7, 2024High impedance; High impedance

  IT WAS REPORTED THAT AT ROUTINE ERI INS BATTERY CHANGE, IMPEDANCES WERE TESTED IN PREOP AND SAW ABNORMAL IMPEDANCES ON RIGHT STN LEA D/EXTENSION--CONTACT 4 SLIGHTLY HIGH AROUND 5K MONOPOLAR <(>&<)> CONTACT 6 ALL PAIRS MONO AND BIPOLAR >20K. THE CIRCUMSTANCES THAT MAY HAVE LED TO THE ISSUE WERE UNKNOWN. THERE WAS DISCUSSION ON CHANGING OUT THE POCKET ADAPTOR BUT THE HCP CHOSE NOT TO. THE HCP SAID THE PATIENT IS PROGRAMMED AROUND THE CONTACTS WITH ISSUES ON THE RIGHT STN LEAD/EXTENSION AND IS DOING WELL WITH DBS THERAPY/GETTING GOOD BENEFIT. IMPEDANCES WERE RAN AFTER CHANGING THE INS AND THERE WERE NO CHANGES IN THE VALUES. THE PATIENT IS NOT PROGRAMMED USING THE ABNORMAL IMPEDANCE CONTACTS 4 AND 6. THE ISSUE WAS RESOLVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858188 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE DEATH CERTIFICATE INDICATED ¿CEREBRAL VASCULAR DISEASE¿ AND THAT THE DBS NEUROLOGIST INDICATED THE PATIENT HAS LIKELY HAD HUNDREDS OF TIAS WHICH THE HEALTHCARE PROVIDER THOUGHT WAS DUE TO DETERIORATION OF BLOOD VESSELS FROM THE IMPLANTS, SPECIFICALLY THE ¿WIRES AND STUFF DID IT.¿ IT WAS CONFIRMED THE IMPLANT WAS WORKING AS INTENDED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Dysphasia; Fall; Headache; Insufficient Information; Pain; Shaking/Tremors; Transient Ischemic Attack

  MAUDE report 18800812 ↗
• MalfunctionFeb 5, 2024Display or Visual Feedback Problem; Energy Output Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Energy Output Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WANTED THEM TO ADJUST THE IMPLANTED NEUROSTIMULATOR (INS) VOLTAGE BECAUSE ONE OF THEIR LEGS WAS MOVING. THE CALLER MENTIONED THAT THE EVENT OCCURRED A COUPLE OF HOURS AFTER THE PATIENT TOOK THEIR 7 O'CLOCK MEDICATION THIS MORNING. HOWEVER, WHEN THE CALLER ATTEMPTED TO TURN ON THE PROGRAMMER, THE SCREEN WENT BLANK AND WOULD NOT POWER ON. CALLER STATED THAT THEY REPLACED THE BATTERIES BUT THE ISSUE WAS NOT RESOLVED. A REPLACEMENT PROGRAMMER WAS SENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639776 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Failure to Power Up

  INFORMATION RECEIVED FROM A CONSUMER REPORTED THE PROGRAMMER WAS DROPPED AND NO LONGER POWERED ON EVEN AFTER THE BATTERIES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634569 ↗
• MalfunctionFeb 1, 2024Failure to Interrogate; Mechanical Problem; Failure to Power Up; Battery Problem; Communication or Transmission Problem; Failure to Interrogate; Mechanical Problem; Failure to Power Up; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE 006 CALL YOUR DOCTOR CODE CAME UP ON THE PATIENT PROGRAMMER YESTERDAY. PATIENT (PT) SAID THEY WEREN'T ABLE TO GET THE PATIENT PROGRAMMER TO POWER ON UNLESS THEY TOOK THE AAA BATTERIES OUT AND PUT THEM BACK IN. PT SAID THAT THE SYNC BUTTON SEEMED TO BE STUCK BECAUSE WHEN THEY PRESSED IT THE CHECK MARK (SYNC SCREEN) STAYED THE SAME AND DIDN'T PROGRESS TO CONNECTING WITH INS. PT TOOK AAA BATTERIES OUT OF PATIENT PROGRAMMER AND PRESSED AND RELEASED ALL KEYS ON THE PATIENT PROGRAMMER BUT PT STILL WASN'T ABLE TO POWER ON PATIENT PROGRAMMER LIKE NORMAL WITH ON/OFF BUTTON, PATIENT PROGRAMMER CAME BACK ON ONCE AAA BATTERIES WERE TAKEN OUT AND PUT BACK IN. PT SAID THAT THE AAA BATTERIES WEREN'T LASTING AS LONG AS NORMAL AND SAID THEY PUT NEW BATTERIES IN ABOUT A MONTH AGO AND THEY WERE ALREADY DECREASED. PT SAID THEY HAD BEEN TRAVELING AND THE PATIENT PROGRAMMER HAD BEEN THROUGH AIR PORT X-RAY SECURITY AND COULD'VE BEEN BANGED UP. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT CONFIRMED THEY RECEIVED THE REPLACEMENT PATIENT P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628424 ↗
• MalfunctionFeb 1, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT PATIENT (PT) REPORTED PATIENT PROGRAMMER SHOWED THE "PATIENT PROGRAMMER BATTERIES DEPLETED" WARNING SCREEN. NEW BATTERIES WERE PUT IN THE PATIENT PROGRAMMER BUT NOW PATIENT PROGRAMMER WON'T POWER ON. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621443 ↗
• MalfunctionFeb 1, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS NOT POWERING ON. PATIENT REPRESENTATIVE STATES ALREADY REPLACING BATTERIES AND BOUGHT NEW BATTERIES BUT THAT DID NOT RESOLVE THE ISSUE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621386 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT POWER ON WITH TWO NEW SETS OF AAA BATTERIES. THE PATIENT SAW NO PHYSICAL DAMAGE INSIDE PATIENT PROGRAMMER BATTERY COMPARTMENT. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611023 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, 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.