Activa® PC 37601 (UDI 00613994934604)Recalls & reported problems

Summary

The FDA's MAUDE database contains 521 adverse event reports that list this exact device (DI 00613994934604), received between Jul 12, 2013 and May 1, 2026 — classified as 3 deaths, 271 injuries, 247 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (92 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 521 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THEY ARE DOING A DBS BATTERY REPLACEMENT FOR THE PATIENT AND THEY ARE NOT ABLE TO FIND THE PART NUMBERS FOR THE EXTENSIONS OR LEADS ANYWHERE IN THE NOTES. REPRESENTATIVE STATES THE PATIENT'S BATTERY IS ""COMPLETELY DEAD"" AND THEY CAN'T PULL THE SETTINGS FROM THE BATTERY. AGENT ASKED FOR EVENT DATE AND CALLER STATES ""SOMETIME IN THE LAST MONTH OR SO"" AND WHEN THEY CHECKED THE PROCEDURE NOTE FROM 2 WEEKS AGO, THE PATIENT SAID THEY CAME TO THE OFFICE AND THE BATTERY WAS DEAD. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058712 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO DBS IMPLANTS FOR DYSTONIA AND NEITHER OF THEM WORKED. CALLER DID NOT KNOW WHY. CALLER STATED THE FIRST ONE WAS IMPLANTED BY AN HCP WHO LOST THEIR LICENSE. THE 2ND TIME PATIENT WENT TO A NEW PHYSICIAN AND THEY WENT THROUGH ALL THE SETTINGS.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24634650 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPOSED IMPLANTED HARDWARE, WOUND DEHISCENCE, AND INFECTION OCCURRED. THE PATIENT REPORTED AN UNRELATED SKIN INJURY TWO WEEKS PRIOR TO PRESENTING TO MEDICAL STAFF, STATING THE INJURY WAS THE RESULT OF A FALL. EXAMINATION CONFIRMED WOUND DEHISCENCE AND EXPOSED HARDWARE. THE HARDWARE, INCLUDING THE LEAD, EXTENSION, AND IMPLANTABLE PULSE GENERATOR (IPG), WAS FUNCTIONING PROPERLY BUT WAS REMOVED DUE TO INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED. THE WOUND HEALED, AND THE PATIENT OPTED NOT TO RE-IMPLANT. THE EVENT WAS ASSESSED AS NOT RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24501472 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REP MENTIONED HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED 3 TIMES AND HAVING CORDS REPLACED BEFORE. DID NOT ASK FURTHER DETAILS DUE TO NATURE OF CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027387 ↗
• MalfunctionOct 20, 2025High impedance; Unintended Collision; High impedance; Unintended Collision

  IT WAS REPORTED THAT THE PATIENT HAD WORSENING OF PARKINSON'S DISEASE (PD) SYMPTOMS AND TWO SIGNIFICANT FALLS IN (B)(6) 2024 AND (B)(6) 2024. IMPEDANCE TESTS WERE DONE AND ELEVATED IMPEDANCES WERE FOUND ON CONTACT 8 AND 9.

  Patient problems: Insufficient Information

  MAUDE report 23335898 ↗
• MalfunctionAug 27, 2025Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION STATED THAT THE RESISTANCE WAS HIGHER THAN A RANGE ATTRIBUTED TO FLUID. THE OUT-OF-RANGE IMPEDANCES STARTED ON (B)(6) 2017 AND WAS NOT A NEW PROBLEM. DURING THE MOST RECENT VISIT ON (B)(6) 2025 ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. THE CAUSE WAS UNKNOWN BUT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907610 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF BENEFIT FROM STIMULATION WITH THE DEVICE, LEADING TO SPEECH PROBLEMS, RIGHT LEG ISSUES, AND TREMOR CONTROL DIFFICULTIES. THE DEVICE INVOLVED WAS A LEAD TARGETING THE LEFT VIM. INITIALLY, THE PATIENT EXPERIENCED SIGNIFICANT RELIEF AND WAS ABLE TO ENGAGE IN WORK INVOLVING HANDS AND MECHANICAL ENGINEERING PROJECTS. HOWEVER, OVER TIME, ACHIEVING THE SAME LEVEL OF CONTROL BECAME INCREASINGLY DIFFICULT WITHOUT SIGNIFICANTLY INCREASING THE UNIT'S SETTINGS, WHICH THEN CAUSED ADDITIONAL SPEECH AND RIGHT LEG PROBLEMS. IT WAS NOTED THAT WHILE THE LEFT-SIDED IMPLANT WAS FUNCTIONING, IT WAS NOT OPTIMAL FOR TREMOR CONTROL. AN EXAMINATION CONFIRMED THE LOSS OF BENEFIT. AS A RESULT, THE LEAD AND EXTENSION COMPONENTS WERE EXPLANTED AND REPLACED ON (B)(6) 2016, AND (B)(6) 2016, RESPECTIVELY. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Dysphasia; Insufficient Information; Shaking/Tremors

  MAUDE report 22096918 ↗
• InjuryDec 11, 2024Battery Problem; Noise, Audible; Battery Problem; Noise, Audible

  IT WAS REPORTED THAT THEIR IMPLANT BATTERY REPLACED BACK IN 2018 BECAUSE THEIR BATTERY DIED AND THEY "HEARD A LOUD SOUND" AND THEN THEY STARTED TO SHAKE ALL OVER. PATIENT STATED THEY WERE TOLD THEIR CURRENT IMPLANT WOULD BE GOOD FOR 15 YEARS.

  Patient problems: Shaking/Tremors

  MAUDE report 20901487 ↗
• MalfunctionAug 13, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING ROUTINE DEVICE INTERROGATION, IT WAS FOUND THERE WAS HIGH IMPEDANCE FOR THE RIGHT GLOBUS PALLIDUS (GPI) LEAD ON ELECTRODE 11. THIS HAS NOT CAUSED ANY ISSUES. A DIFFERENT SETTING WAS USED. THE ISSUE IS UNRESOLVED WITH NO FURTHER ACTION PLANNED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE EXACT CAUSE OF THE HIGH IMPEDANCE IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WERE SEVERAL ROUTINE DEVICE INTERROGATIONS. THIS CONTACT IS NOT USED FOR PROGRAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977896 ↗
• MalfunctionJul 23, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE MANUFACTURER'S REPRESENTATIVE (REP) THAT THE PATIENT'S INS WAS REPLACED ON 07/15/2024, AND PRIOR TO REPLACEMENT, THE CALLER ATTEMPTED TO RUN THERAPY IMPEDANCE BUT NEVER RECEIVED A VALUE; THE RESULT KEPT SHOWING AS JUST A LINE. THE REP CONFIRMED THAT THE BATTERY VOLTAGE WAS 2.52V AND THE AMPLITUDE WAS SET TO THERAPEUTIC LEVELS (AS OPPOSED TO BEING AT 0V), SO THE THERAPY IMPEDANCE SHOULD HAVE PROVIDED A NUMERICAL RESULT. THE REP COULD RUN ELECTRODE IMPEDANCE WITHOUT ISSUE AND TRIED TURNING THE INS OFF AND BACK ON, BUT WITH NO RESOLUTION. TROUBLESHOOTING WAS NOT REQUIRED. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. THE PATIENT'S INS WAS REPLACED WITHOUT ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) ON 07/17/2024 CONFIRMED WITH THE CONSUMER THAT THE BATTERY WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE CAUSE OF THE NO VALUE IMPEDANCE ISSUE REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809554 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEE A. T., HAN K. J., NICHOLS N., SUDHAKER V. R., BURKE J. F., WOZNY T. A., CHUNG J. E., VOLZ M. M., OSTREM J. L., MARTIN A. J., LARSON P. S., STARR P. A., WANG D. D. TARGETING ACCURACY AND CLINICAL OUTCOMES OF AWAKE VERSUS ASLEEP INTERVENTIONAL MAGNETIC RESONANCE IMAGING-GUIDED DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: THE UNIVERSITY OF CALIFORNIA, SAN FRANC NEUROSURGERY 2022 DOI: 10.12 27/NEU.0000000000002111 ABSTRACT: BACKGROUND: INTERVENTIONAL MRI (IMRI)-GUIDED IMPLANTATION OF DEEP BRAIN STIMULATOR (DBS) LEADS HAS BEEN DEVELOPED TO TREAT PATIENTS WITH PARKINSON¿S DISEASE (PD) WITHOUT THE NEED FOR AWAKE TESTING. OBJECTIVE: DIRECT COMPARISONS OF TARGETING ACCURACY AND CLINICAL OUTCOMES FOR AWAKE STEREOTACTIC WITH ASLEEP IMRI-DBS FOR PD ARE LIMITED. METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF PATIENTS WITH PD WHO UNDERWENT AWAKE OR IMRI-GUIDED DBS SURGERY TARGETING THE SUBTHALAMIC NUCLEUS OR GLOBUS PALLIDUS INTERNA BETWEEN 2013 AND 2019 AT OUR INSTITUTION. OUTCOME MEASURES INCLUDED UNIFIED PARKINSON¿S DISEASE RATING SCALE PART III SCORES, LEVODOPA EQUIVALENT DAILY DOSE, RADIAL ERROR BETWEEN INTENDED AND ACTUAL LEAD LOCATIONS, STIMULATION PARAMETERS, AND COMPLICATIONS. RE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19049264 ↗
• MalfunctionMar 19, 2024Unable to Obtain Readings; Unable to Obtain Readings

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE CALLER REPORTED THAT THEY WERE TRYING TO CHECK THERAPY IMPEDANCE AND THE CALLER INDICATED THAT THEY WERE NOT GETTING A NUMERICAL VALUE. THE THERAPY IMPEDANCE RESULT WAS DISPLAYING "---". THE CALLER INDICATED THAT THEY TRIED RE-INTERROGATING MULTIPLE TIMES AND RERUNNING IMPEDANCE. THE CALLER INDICATED THAT THEY GOT THE SAME RESULT (VALUE OF ---) DURING THE SECOND INTERROGATION. DURING THE THIRD INTERROGATION THE PROGRAMMER ENDED THE SESSION AUTOMATICALLY. THE CALLER INDICATED THAT THE INS IS PROGRAMMED WITH TWO LEADS BUT THE PATIENT HAS ONLY ONE LEAD IMPLANTED. THE PATIENT REPORTED THAT THEY PLANNED TO PLACE A SECOND LEAD BUT NEVER DID. TSS REVIEWED THAT THEY SHOULD STILL BE ABLE TO RUN THERAPY IMPEDANCES. DURING THE CALL, THE CALLER INTERROGATED AND GOT THE THERAPY IMPEDANCE VALUE FOR GROUP B. THE CALLER THEN SWITCHED GROUPS AND THE THERAPY IMPEDANCE DISPLAYED THE SAME "---" RESULT. TECH SERVICES (TSS) PROVIDED THE FOLLOWING INFORMATION FOR THE CURRENT CONVERSION: A C+ 2- 2V MONOPOLAR IMP: 845 ESTIMATED CURRENT: 2.3MAC C+ 0- 1.5V MONOPOLAR IM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933501 ↗
• MalfunctionMar 13, 2024Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  PATIENT REP REPORTED THEY WERE ABLE TO POWER ON THE PATIENT PROGRAMMER, BUT THEY KEPT GETTING THE 'POOR COMMUNICATION' SCREEN WHEN THEY TRIED TO SYNCHRONIZE THE PROGRAMMER WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS NOT USING AN ANTENNA AND THE REP CONFIRMED THE PROGRAMMER WAS POSITIONED OVER THE INS. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER. PATIENT REP CALLED BACK AND STATES THEY RECEIVED THE REPLACEMENT PROGRAMMER, BUT THE PROGRAMMER IS STILL SHOWING POOR COMMUNICATION. PATIENT SERVICES REDIRECTED REP TO PATIENT'S HEALTHCARE PROVIDER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895692 ↗
• MalfunctionFeb 6, 2024Failure to Deliver Energy; Failure to Power Up; Battery Problem; Failure to Deliver Energy; Failure to Power Up; Battery Problem

  PATIENT SERVICES (PSS) RECEIVED CALL FROM PATIENT STATING THAT THE 37642 IS NOT WORKING. THE CALLER STATED THAT THEY CHANGED THE BATTERIES OF THE PATIENT PROGRAMMER AND THEY ARE SEEING A ERI MESSAGE WHEN THEY TRY TO CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN PSS ASKED THE CALLER WHEN THEY STARTED SEEING THE ERI MESSAGE THEY RESPONDED "RECENTLY". PSS REVIEWED WITH THE CALLER ERI AND EOS FOR THEIR INS. ON THE CALL PSS HAD THE CALLER SYNCHRONIZE THE PATIENT PROGRAMMER WITH THE INS AND THE PATIENT CONFIRMED TO SEEING "OFF" FOR INS , ERI AND .7 C .7 ON THE PATIENT PROGRAMMER SCREEN. THE CALLER STATED THAT THE INS IS AT 2.58V. THE CALLER WAS ABLE TO TURN ON THERAPY WHILE ON CALL. PSS REDIRECTED THE CALLER TO HCP TO FURTHER ASSIST WITH THE ERI MESSAGE , AND DISCUSS GETTING THE INS REPLACED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE BATTERY RAN OUT SO SURGERY WAS GOING TO TAKE PLACE ON (B)(6), 2023 TO RESOLVE THE DEVICE REACHING ERI AND TURNING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650988 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT THEIR SPEECH WAS AFFECTED WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON. THE PATIENT SAID THEIR SPEECH WAS NOT AFFECTED WHEN THE INS WAS TURNED OFF. THE PATIENT MENTIONED THAT THEY FELT LIKE THEY HAD TO CHOOSE BETWEEN THEIR MOVEMENT DISORDER AND THEIR SPEECH, SO THEY CHOSE TO HAVE THE MOVEMENT DISORDER AND NORMAL SPEECH. THEN, THE PATIENT STATED THAT THEIR INS BATTERY WAS "OUT OF JUICE," BUT THEY NEVER GOT IT REPLACED BECAUSE OF HOW IT AFFECTED THEIR SPEECH WHENEVER THE INS WAS TURNED ON. AGENT WAS UNABLE TO CONFIRM THAT THE PATIENT'S INS REACHED EOS BECAUSE THE PATIENT DID NOT HAVE THEIR PATIENT PROGRAMMER WITH THEM, BUT THE PATIENT STATED THAT THEY DID SEE A SCREEN ON THE PATIENT PROGRAMMER THAT INDICATED THE INS HAD REACHED EOS. THE PATIENT'S REASON FOR CALLING WAS BECAUSE THEY HAD A STROKE THIS PAST MONTH AND THEIR HEALTHCARE PROVIDER (HCP) WANTS TO DO AN MRI. THE PATIENT MENTIONED THAT THEY SPOKE WITH PATIENT SERVICES EARLIER TODAY ABOUT MRI COMPATIBILITY AND WERE REDIRECTED TO THEIR MANAGING HCP FOR ASSISTANCE. THE PATIENT STATED THAT THEY CALLED THEIR MANAGING HCP, BUT THE HCP TOLD THE PATIENT THAT THEY ONLY KEEP THEIR RECORDS FOR 7 YEARS, AND

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

  MAUDE report 18628994 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE CALLER HAD A FRAYED RECHARGER ANTENNA CORD AND PATIENT PROGRAMMER WON'T TURN ON WITH NEW BATTERIES.  NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607434 ↗
• MalfunctionJan 16, 2024Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR.  THE CALLER WALKED THE CALLER THROUGH THE STEPS OF CONNECTING THE EQUIPMENT WITH NO ISSUE. THE CALLER STATED THAT THE THERAPY WAS TOGGLED OFF, BUT CONFIRMED TO TURNING THE THERAPY ON. THE CALLER STATED THAT THEY HAVE NOT HAD ANY PROCEDURES RECENTLY, AND STATED THAT THEY HAVE NOT SEEN THE HCP SINCE BEING IMPLANTED. ALL QUESTIONS WERE ADDRESSED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519546 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION IN THE NECK AROUND THE LEAD/EXTENSION CONNECTION SITE AND THE ENTIRE SYSTEM WAS BEING REMOVED. THE SURGERY OCCURRED AS EXPECTED; EXTENSIONS, LEADS AND BURR HOLES WERE ALL REMOVED. PATIENT PREVIOUSLY HAD DEEP BRAIN STIMULATION (DBS) GENERATOR REMOVED IN 2014 DUE TO AN INFECTION AND THE GENERATOR WAS NEVER REPLACED. DIAGNOSTICS AND TROUBLESHOOTING PERFORMED INCLUDED CULTURE INSPECTION AND CONFIRMED INFECTION. THE ISSUE WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 18446135 ↗
• MalfunctionDec 19, 2023Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE CALLER REPORTED THAT THE PATIENT'S ORIGINAL DBS SYSTEM ONLY LASTED 4-5 YEARS. THE PATIENT HAD TWO DBS SYSTEMS PRIOR TO THE ACTIVA RC, AND IT WAS UNCLEAR WHICH THE CALLER WAS REFERRING TO. AGENT ATTEMPTED TO GET CLARIFICATION AND THE CALLER STATED, "I THINK THEY SAID THEY PUT IN A CRAPPY BATTERY" AND "THE SETTINGS WERE SO HIGH IT WORE THAT BATTERY OUT."  NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY REQUESTED A ¿NEW BATTERY BECAUSE THE BATTERY WASN¿T WORKING, BUT NOW IT¿S WORKING.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355926 ↗
• MalfunctionNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN MRI DONE ON (B)(6) 2023 AND THE PATIENT'S WIFE CHECKED THE BATTERY AND IT STILL SAYS IT'S IN MRI MODE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241304 ↗
• MalfunctionNov 15, 2023Energy Output Problem; Vibration; Energy Output Problem; Vibration

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SOFTWARE UPDATE LAST FRIDAY BY UPGRADING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FROM 9 YEARS TO 15 YEARS. AFTER RECEIVING THE UPGRADE THEIR INS HAD BEEN SHAKING AND MAKING THEM FEEL LIKE THEY WERE GOING TO VOMIT.

  Patient problems: Device Overstimulation of Tissue; Nausea

  MAUDE report 18139174 ↗
• InjuryNov 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S PREVIOUS NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATORS (INS) DID NOT LAST AS LONG AS THEY EXPECTED. THE PATIENT STATED THAT THEY EXPECTED EACH OF THE NON-RECHARGEABLE INSS TO LAST 5 YEARS, BUT EACH OF THEM LASTED LESS THAN 3 YEARS. IT WAS REVIEWED THAT THE LONGEVITY OF A NON-RECHARGEABLE INS DEPENDS ON THE USAGE AND PROGRAMMING/ SETTINGS. THE PATIENT STATED THEY ELECTED TO GET THE RECHARGEABLE CELL INS SO THEY WOULD NOT NEED TO GET SURGERY AS FREQUENTLY. THE PATIENT MENTIONED THAT IT'S HARDER FOR THEM TO RECOVER FROM SURGERY AS THEY GET OLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120684 ↗
• MalfunctionSep 29, 2023High impedance; Unintended Collision; High impedance; Unintended Collision

  IT WAS REPORTED THAT AN IMPEDANCE TEST WAS RUN AND SHOWED AN ORANGE FLAG AND IMPEDANCE VALUES GREATER THAN 5000. THE MANUFACTURER REPRESENTATIVE (REP) INQUIRED IF THE PATIENT COULD HAVE AN MRI. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER REPRESENTATIVE (REP), WHO REPORTED THE HIGH IMPEDANCE VALUE WAS SHOWN AT THE RIGHT SIDE LEAD/EXTENSION. THE CAUSE REMAINS UNKNOWN, BUT POSSIBLY DUE TO A FALL. NO ACTIONS/SURGERY ARE PLANNED TO RESOLVE THE IMPEDANCES. THE THERAPY PROGRAMMING IS WORKING AROUND HIGH IMPEDANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841933 ↗
• MalfunctionAug 25, 2023Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  IT WAS REPORTED THAT THE PATIENT NEEDS AN MRI. CALLER DID NOT ALLEGE ANY ISSUE OF PATIENT BEING IN HOSPITAL DUE TO DBS. CALLER STATES THE HOSPITAL HAS BEEN TRYING TO REACH A MANUFACTURER REPRESENTATIVE (REP). AGENT ASKED IF THE PATIENT HAD A PROGRAMMER AND CALLER STATES NO, THE PATIENT NEVER HAD A PROGRAMMER. CALLER STATES LAST YEAR THE IMPLANTED NEUROSTIMULATOR (INS) BATTERY WAS RUNNING QUITE LOW AND THEY THINK IT IS PROBABLY OFF AND PATIENT HAD SO MANY DEFICITS THE PHYSICIAN DECIDED NOT TO DO ANYTHING WITH IT. AGENT REVIEWED THE REPRESENTATIVE WOULD USUALLY NEED TO BE INVITED IN BY HEALTHCARE PROVIDER. CALLER MENTIONED A FEW YEARS AGO THE HOSPITAL CALLED THE REPRESENTATIVE AND THE REPRESENTATIVE MET WITH THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17623570 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED IN 2014 THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) FELL OUT OF THEIR CHEST.

  Patient problems: Pocket Erosion

  MAUDE report 17238563 ↗

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.