Activa® SC 37603 (UDI 00763000100353)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00763000100353), received between Mar 20, 2020 and Mar 9, 2026 — classified as 2 deaths, 48 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE CAUSE OF THE LOW IMPEDANCE WAS UNKNOWN. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. DETERMINED?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552138 ↗
• InjuryMar 4, 2026Battery Problem

  IT WAS REPORTED THAT FOR 3 MONTHS THEY HAVE NOTICED UNCONTROLLED TREMOR ON THEIR RIGHT SIDE AND HAVE BEEN INCREASING AMPLITUDE BECAUSE OF THAT. THEY HAVE BEEN MONITORING THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WHICH DROPPED FROM 2.6 TO 2.59 OVER THE SPAN OF 3-4 DAYS WHICH PATIENT WAS CONCERNED WAS REALLY FAST, AND PATIENT WONDERED WHY IT HAD NOT TRIGGERED ERI YET. REVIEWED ERI OCCURS AT 2.58V. PATIENT REPORTED THEY HAD BATTERY REPLACEMENT ORIGINALLY SCHEDULED FOR TOMORROW BUT THEIR SURGEON CANCELLED AND RESCHEDULED IT FOR 8 WEEKS AWAY. PATIENT ADDITIONALLY REPORTED THAT THEY DO NOT LIKE HOW HIGH UP THEIR RIGHT SIDE BATTERY WAS PLACED AND IT HAS BOTHERED THEM SINCE IMPLANT. PATIENT ALSO STATED THAT THEIR SURGEON THOUGHT PATIENT MAY HAVE PULLED THE WIRES OUT OF THE BATTERY. RECOMMENDED PATIENT DISCUSS THESE CONCERNS WITH THEIR PHYSICIAN.

  Patient problems: Shaking/Tremors

  MAUDE report 24512469 ↗
• InjuryMar 4, 2026Malposition of Device; Battery Problem

  IT WAS REPORTED THAT FOR 3 MONTHS THEY HAVE NOTICED UNCONTROLLED TREMOR ON THEIR RIGHT SIDE AND HAVE BEEN INCREASING AMPLITUDE BECAUSE OF THAT. THEY HAVE BEEN MONITORING THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WHICH DROPPED FROM 2.6 TO 2.59 OVER THE SPAN OF 3-4 DAYS WHICH PATIENT WAS CONCERNED WAS REALLY FAST, AND PATIENT WONDERED WHY IT HAD NOT TRIGGERED ERI YET. REVIEWED ERI OCCURS AT 2.58V. PATIENT REPORTED THEY HAD BATTERY REPLACEMENT ORIGINALLY SCHEDULED FOR TOMORROW BUT THEIR SURGEON CANCELLED AND RESCHEDULED IT FOR 8 WEEKS AWAY. PATIENT ADDITIONALLY REPORTED THAT THEY DO NOT LIKE HOW HIGH UP THEIR RIGHT SIDE BATTERY WAS PLACED AND IT HAS BOTHERED THEM SINCE IMPLANT. PATIENT ALSO STATED THAT THEIR SURGEON THOUGHT PATIENT MAY HAVE PULLED THE WIRES OUT OF THE BATTERY. RECOMMENDED PATIENT DISCUSS THESE CONCERNS WITH THEIR PHYSICIAN.

  Patient problems: Discomfort; Shaking/Tremors

  MAUDE report 24506662 ↗
• MalfunctionNov 24, 2025Energy Output Problem; Loss of Data; Data Problem; Energy Output Problem; Loss of Data; Data Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) THAT THE CAUSE WAS UNKNOWN. THEY REPORTED THAT THE PATIENT WAS ABLE TO RESOLVE THE PROBLEM ON THEIR OWN AND IS NOW DOING FINE.

  Patient problems: Ambulation or Postural Difficulties; Lethargy

  MAUDE report 23640627 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH DYSTONIA WHO HAD RECEIVED THE ACTIVA SCX. NEUROSTIMULATOR EXPERIENCED PAIN WITH HEAD MOVEMENT ON THE LEFT SIDE, WHICH WAS LIKELY DUE TO ADHESIONS. THE PATIENT DID NOT FOLLOW POST-OPERATIVE INSTRUCTIONS TO STRETCH THE NECK, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF ADHESIONS. NORMAL BATTERY DEPLETION OF THE NEUROSTIMULATOR WAS ALSO IDENTIFIED. SURGICAL REPLACEMENT OF BOTH THE EXTENSION AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 23511704 ↗
• MalfunctionOct 28, 2025Impedance Problem; Adverse Event Without Identified Device or Use Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS INITIALLY RECEIVED FROM A PATIENT'S REPRESENTATIVE THE PATIENT HAD NOT BEEN USING THE EQUIPMENT AND HIS TREMORS WERE COMING BACK. CALLER STATES NOTICING TREMORS AROUND THE 25TH OF JULY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) DURING FOLLOW UP TO OBTAIN ADDITIONAL INFORMATION THAT THE PATIENT WAS UNABLE TO HAVE AN MRI DUE TO A FAILED IMPEDANCE CHECK. SEE MANUFACTURER¿S REPORT # 3004209178-2025-18330.

  Patient problems: Shaking/Tremors

  MAUDE report 23405637 ↗
• MalfunctionSep 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN IMPLANTED PAST THE USE-BY DATE (UBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026828 ↗
• MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) STATED THAT ONE OF THE ELECTRODES IN THE SYSTEM WAS BROKEN. THE PATIENT CLARIFIED THAT THE DEVICE WAS PROGRAMMED SO THAT THE BROKEN ELECTRODE WAS NOT USED. A MAGNETIC RESONANCE IMAGING (MRI) ELIGIBILITY FORM WAS REVIEWED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22797143 ↗
• InjuryMar 20, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. PATIENT REPORTED THAT THE IMPLANTABLE DEVICE LASTED 5 YEARS AS IT WAS EXPECTED. PATIENT REPORTED THAT SWITCHING TO A RECHARGEABLE NEUROSTIMULATOR RESOLVED ISSUE OF BATTERIES GOING TOO QUICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653282 ↗
• MalfunctionJan 24, 2025High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED NO FURTHER ACTIONS WERE PLANNED AT THIS TIME AS THE PATIENT WAS NOT USING THAT CONTACT FOR THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21235959 ↗
• MalfunctionJan 2, 2025Battery Problem; Electromagnetic Compatibility Problem; Battery Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT A PATIENT'S SYMPTOMS HAVE BECOME MORE PROFOUND OVER THE PAST YEAR, INCLUDING FREQUENT FALLS, CONFUSION, SLEEP DISTURBANCES, AND SPEECH DIFFICULTIES. ADDITIONALLY, THE NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR WAS NOT DEPLETING AS EXPECTED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THESE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHO REPORTED THE PATIENT¿S NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT SHOWN ANY DROP AT ALL IN THE VOLTAGE SINCE THE PATIENT GOT THE RECHARGEABLE IMPLANT WHICH WAS PRETTY UNUSUAL. THE CONSUMER STATED SOMEHOW THE RECHARGEABLE IMPLANT WAS INTERFERING WITH IT WITH THE POSSIBILITY THEY COULDN¿T TELL IF THE BATTERY WAS ACTUALLY DEPLETING DUE TO ELECTROMAGNETIC INTERFERENCE WITH THE "READ OUT". THE CONSUMER STATED IT WAS ODD FOR TWO YEARS NOT TO HAVE IMPLANT DROP AT ALL. IT WAS NOTED THE PATIENT WAS FALLING A LOT. THE PATIENT RECENTLY SAW THE PHYSICIAN WHO CHECKED THE IMPLANT WHICH SHOWED THE BATTERY HADN¿T DEPLETED WITH THEIR PREVIOUS NON-RECHARGEABLE IMPLANTS NOT HAVING THIS ISSUE (THEY DIDN¿T THINK THE THERAPY SETTINGS WERE ANY DIFFERENT EITHER). THE CONSU MER MENTIONED

  Patient problems: Confusion/ Disorientation; Dysphasia; Fall; Sleep Dysfunction

  MAUDE report 21053605 ↗
• MalfunctionDec 27, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT DURING A NORMAL BATTERY REPLACEMENT PROCEDURE FOR A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG), THERE WAS AN IMPEDANCE ISSUE. SPECIFICALLY, WHILE USING MONOPOLAR PROGRAMMING, THE IMPEDANCES WERE NORMAL, BUT THEY WERE OUT OF RANGE WHEN USING BIPOLAR PROGRAMMING. THE PATIENT WAS PROGRAMMED IN A DOUBLE MONOPOLAR CONFIGURATION. TECHNICAL SERVICES PROVIDED INFORMATION REGARDING THE EFFECTS OF MONOPOLAR VERSUS BIPOLAR PROGRAMMING ON MAGNETIC RESONANCE IMAGING (MRI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028681 ↗
• MalfunctionSep 3, 2024Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S (PT) REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE CALLER REPORTED ABOUT A WEEK AGO, THE PATIENT'S RIGHT ARM, WHICH IS NORMALLY THEIR GOOD ARM, STARTED JERKING AND FLAILING AND THEY COULD NOT CONTROL IT. CALLER SAID THE PROGRAMMER WAS IN A DRAWER, IT WAS UNTOUCHED, THEY PUT NEW BATTERIES IN IT, THEY CHECKED THE PROGRAMMER AND NOTICED THEIR AMPLITUDE NUMBER WAS UNEXPECTEDLY AT 3.4 WHEN IT SHOULD HAVE BEEN AT 2.9, THEY HAVE NO IDEA HOW IT JUMPED FROM 2. 9 TO 3. 4. CALLER SAID THEY USED THE PROGRAMMER AND BROUGHT THE NUMBER BACK DOWN TO WHERE IT BELONGED AND GOT THE PT'S SYMPTOMS UNDER CONTROL. CALLER SAID THEY WENT TO THE DOCTOR'S OFFICE YESTERDAY, THE AMPLITUDE NUMBERS WERE MOVED TO STABILIZE THE PT IN THE OFFICE AND DURING THE APPOINTMENT SPOKE TO THE MEDTRONIC REPRESENTATIVE, GREG ( UNK LAST NAME) AND THE DOCTOR WHO SUGGESTED THEY CALL PATS TO GET A REPLACEMENT FOR THE PATIENT PROGRAMMER TO RULE IT OUT AS A POTENTIAL CAUSE FOR THE AMPLITUDE NUMBERS UNEXPECTEDLY CHANGING. WORKED WITH CALLER TO CHECK THE EQUIPMENT FOR DAMAGE AND CALLER SAID THERE WAS NO VISIBLE DAMAGE. THE ISSUE WAS NOT RESOLVED THROUGH TR

  Patient problems: Cramp(s) /Muscle Spasm(s); No Clinical Signs, Symptoms or Conditions; Twitching

  MAUDE report 20131903 ↗
• MalfunctionAug 14, 2024Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  THE PATIENT REPORTED THEY HAVE BEEN HAVING PROBLEMS WITH THEIR HANDS SHAKING MORE THAN THEY SHOULD BE FOR THE PAST 6 MONTHS. THEY CAN'T EVEN EAT BECAUSE THEIR HANDS ARE SHAKING SO BAD. THEIR RIGHT HAND IS THE HAND THAT IS SHAKING WHICH IS THE SIDE THEY HAD THE DBS IMPLANTED TO TREAT. PATIENT WAS CONCERNED ABOUT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LONGEVITY STATING THAT THEY FELT IT SHOULD HAVE LASTED MORE THAN 3.5 YEARS. PATIENT SERVICES REVIEWED LONGEVITY EXPECTATIONS. PATIENT HAD THE INS BATTERY CHECKED BY THEIR NEUROLOGIST WHO TOLD THEM THE BATTERY WAS NO LONGER WORKING. PATIENT HAS A FOLLOW UP APPOINTMENT SCHEDULED WITH THEIR DOCTOR TO DISCUSS INS BATTERY REPLACEMENT.

  Patient problems: Shaking/Tremors

  MAUDE report 19982804 ↗
• InjuryAug 5, 2024Break; Break

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE PATIENT'S EXTENSION WAS SEVERED AT THE CONNECTION POINT BETWEEN THE EXTENSION WIRE AND THE INS ADAPTOR. THE PATIENT PRESENTED WITH THE LEFT BATTERY STIMULATION OFF DUE TO ITS INEFFECTIVENESS. THE PA TIENT SUSPECTED IT WAS DUE TO "COMPATIBILITY ISSUES" WITH HAVING A MIXED SYSTEM. DURING THE OPERATION, IT WAS DISCOVERED THAT THE EXTENSION WIRE HAD COMPLETELY SEVERED FROM THE BATTERY AT THE POINT OF THE BOSTON SCIENTIFIC ADAPTOR. THE CAUSE WAS UNKNOWN. THE PATIENT DIDN'T RECALL A SINGLE EVENT IN WHICH THE BREAK OCCURRED. THE EXTENSION WAS REPLACED ON (B)(6) 2024. THE IMPEDANCES WERE NORMAL WITH THE NEW EXTENSION WIRE, INDICATING NO ISSUES WITH THE LEAD. THE PROBLEM WAS RESOLVED BY THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURIES. SEE (B)(4) FOR BSC INS OFF DUE TO 'INEFFECTIVENESS.' ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) ON 2024 JUL-22 CONFIRMING THE PATIENT WAS IN SURGERY FOR NORMAL BATTERY REPLACEMENT. THE LEFT CHEST BOSTON SCIENTIFIC BATTERY (UNKNOWN MODEL AND SN) WAS TURNED OFF AT THE TIME OF THE PATIENT'S ARRIVAL AT THE HOSPITAL FOR A RETURN TO A FULLY MDT SYSTE

  Patient problems: Insufficient Information

  MAUDE report 19903560 ↗
• MalfunctionJun 25, 2024Display or Visual Feedback Problem; Audible Prompt/Feedback Problem; Display or Visual Feedback Problem; Audible Prompt/Feedback Problem

  PATIENT REPORTS THEIR PATIENT PROGRAMMER IS NOT WORKING CORRECTLY. SCREEN SHOWS A COMPUTER CODE LIKE A PARAGRAPH OF LETTER AND NUMBERS. PATIENT MENTIONED THAT OVER THE YEARS, SETTINGS HAVE BEEN OPTIMIZED SO THAT THEIR TREMORS ARE SOMEWHAT UNDER CONTROL BUT HER SPE ECH IS NOT OVERLY AFFECTED. RECENTLY, PATIENT HAD A COMPLICATION OF OSTEONECROSIS OF THE JAW. IN ORDER TO TREAT THE INFECTION THAT IS CAUSING IT, THEY PRESCRIBED THE ANTIBIOTIC DOXYCYCLINE AND AFTER ABOUT A WEEK OF TAKING IT, THEIR TREMORS ARE OUT OF CONTROL. PATIENT ISN'T SURE IF ANTIBIOTIC IS CAUSING WORSE TREMORS. ABOUT 3 DAYS AGO, PATIENT USED THE PROGRAMMER TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS INDICATING THE NORMAL SETTINGS. PATIENT WAITED A FEW DAYS TO SEE IF THE TREMORS GOT BETTER AND THEY DIDN'T. YESTERDAY, PATIENT WANTED TO MAKE SOME ADJUSTMENTS TO THE SETTINGS BUT THE PATIENT PROGRAMMER DISPLAY WAS BLANK EVEN THOUGH THEY REPLACED THE AAA BATTERIES. THE DISPLAY REMAINED BLANK BUT DEVICE DID BEEP. PATIENT REP CALLED BACK AND MENTIONED THAT WHEN THEY INCREASED DBS SETTINGS, IT CAUSED PATIENT'S SPEECH TO NOT BE AS GOOD (SLURRED). REP SAID THEY WILL FOLLOW UP WITH THE PATIENT'S NEUROLOGIST TO ANA

  Patient problems: Dysphasia; Shaking/Tremors

  MAUDE report 19604591 ↗
• InjuryJun 4, 2024Failure to Deliver Energy; Failure to Deliver Energy

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY WERE DIRECTLY OVER THE INTENDED BATTERY WITH THE COMMUNICATOR AND ASSUMED THEY WERE CONNECTED TO THE INTENDED BATTERY (NOT THE EXPLANTED ONE). THE TABLET/COMMUNICATOR DID NOT PROMPT OR REQUEST THERE WERE SEVERAL BATTERIES TO COMMUNICATE WITH, SO THEY ASSUMED IT WAS COMMUNICATIONS TO THE BATTERY THEY WERE DIRECTLY OVER. THE CAUSE OF THE PAIRING ISSUE WASN¿T DETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 19457995 ↗
• 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 (B)(6) 2021 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 19242624 ↗
• MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE TINGLING SENSATION AROUND THE IMPLANT WASN¿T DETERMINED. THE PATIENT CANCELLED THEIR CLINIC APPOINTMENT WITH THEIR PROVIDER BECAUSE THE TINGLING DIDN¿T REOCCUR (CONFIRMED AFTER SPEAKING WITH THE PATIENT'S SPOUSE). IF IT HAPPENED AGAIN THEY WERE GOING TO SEE THEIR PHYSICIAN.

  Patient problems: Paresthesia

  MAUDE report 19066976 ↗
• MalfunctionMar 1, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED BY A HEALTHCARE PROVIDER (HCP) THAT PATIENT INITIALLY SAID THE LEFT SIDE OF THE CHEST IMPLANT IS NOT WORKING, THEN LATER PATIENT TOLD HER THAT BOTH IMPLANTS HAVE BEEN OFF FOR A MONTH. TECHNICAL SERVICES (TS) WAS NOT ABLE TO GET AN UNDERSTANDING AS TO WHY DEVICES ARE NOT WORKING. PATIENT IS IN TRANSITION OF SEEING A NEW DOCTOR. TS WASN'T ABLE TO GET THAT INFORMATION EITHER. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822010 ↗
• MalfunctionFeb 7, 2024Low impedance; Battery Problem; Insufficient Device Problem Information; Low impedance; Battery Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE OOR WASN¿T DETERMINED. THE HCP INSTRUCTED THE PATIENT TO INTERROGATE THEIR IMPLANT PERIODICALLY TO SEE IF THE OOR REOCCURRED. IT WAS UNKNOWN IF THE ISSUE RESOLVED. THE FOLLOWING DAY THE REP STATED THE PATIENT SAW THE OOR MESSAGE AGAIN LAST FRIDAY. THE REP MET WITH THE PATIENT ON FEBRUARY 16TH AND RAN IMPEDANCES AND SAW CONTACTS 2 AND 3 WERE FLUCTUATING LOW TO NORMAL, AND THE BATTERY LEVEL DROPPED FROM 2.87V TO 2.54-.59V AND SHOWING ERI. THE REP REMOVED CONTACTS 2 AND 3 FROM PROGRAMMING.

  Patient problems: Pain; Paresthesia; Shaking/Tremors

  MAUDE report 18661571 ↗
• MalfunctionJan 31, 2024Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614267 ↗
• MalfunctionJan 31, 2024Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614201 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER NOT POWERING ON. PATIENT REPLACED BATTERIES OVER THE WEEKEND BUT THAT DID NOT RESOLVE THE ISSUE. PATIENT STATES GETTING BATTERIES AT HARBOR FREIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605637 ↗
• MalfunctionJan 24, 2024Electromagnetic Interference; Patient Device Interaction Problem; Electromagnetic Interference; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT ACCIDENTALLY WALKED THROUGH A METAL DETECTOR TO GET BACK INTO THE HOTEL THEY WERE STAYING AT IN MEXICO, AND SINCE THEN THE PATIENT HAD SEVERE ANXIETY, COULD NOT SLEEP, THEIR HANDS WERE SHAKING, AND THEY HAD A LOT OF DIFFICULTY BREATHING. THE PATIENT ADDED THAT THEY HAD A LOT MORE PAIN THAN USUAL WHEN WALKING. THE CALLER DOES NOT THINK THE PATIENT FELL PRIOR TO THIS EVENT, BUT THEY THOUGHT THE PATIENT'S SWINGING MOTION WHILE THEY WERE GOLFING MIGHT HAVE "DISLODGED SOMETHING." THE CALLER MENTIONED THAT THE PATIENT WAS ON TOO MANY MEDICATIONS BETWEEN THEIR PARKINSON'S AND ANTI-ANXIETY MEDICATIONS. CALLER DID NOT BRING THE PROGRAMMER WITH THEM, SO IMPLANT STATUS COULD NOT BE DETERMINED. CALLER MENTIONED THE PATIENT SLEPT BETTER LAST NIGHT, AND AT THE TIME OF THE CALL THEY WERE CALM AND NOT SHAKING. DESPITE THE PATIENT FEELING BETTER, THE CALLER REQUESTED TO HAVE SOMEONE CHECK THE P PATIENT'S IMPLANT TO ENSURE IT WAS WORKING CORRECTLY AND NOT OVERSTIMULATING THE PATIENT. THE CALLER STATED THAT THE PATIENT WAS ON VACATION IN MEXICO AT THE TIME OF THE CALL, AND THAT THEY WOULD BE IN MEXICO FOR ANOTHER 2-3 WEEKS. AGENT REDIRECTED THE CALLER TO THE PATIENT'S

  Patient problems: Anxiety; Dyspnea; Pain; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 18571398 ↗

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.