Activa® PC 37601 (UDI 00763000310332)Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00763000310332), received between May 18, 2020 and May 11, 2026 — classified as 58 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED WITH A RECHARGEABLE INS 2-3 DAYS AGO, BECAUSE THEIR OLD INS HAD DIED 2 AND A HALF MONTHS AGO, BUT THEY STILL HAVE "SHAKES". AGENT WALKED THEM THROUGH CONNECTING TO THE INS AND WAS ABLE TO CONFIRM THAT THE THERAPY IS ON. AGENT DOCUMENTED REPORTED EVENTS AND REDIRECTED THEM TO THE HCP TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 25137989 ↗
• MalfunctionMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH THEIR BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059413 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Disconnection; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE PROVIDING UPDATED INFORMATION FOR DEVICE REGISTRATION, THE PATIENT SAID THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO A LEAD MALFUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078577 ↗
• MalfunctionSep 3, 2025High impedance; High impedance

  IT WAS REPORTED FROM A MANUFACTURING REPRESENTATIVE (REP) THAT THEY WENT TO CHECK THE PATIENT'S IMPEDANCES THIS MORNING AND ARE SEEING THAT ON CONTACT 0, THEY ARE GETTING 3352 OHMS FOR MONOPOLAR AND 4000-4500 OHMS FOR BIPOLAR. THE PATIENT IS AN INPATIENT DUE TO REASONS UNRELATED TO THE STIMULATOR. REP DID NOT KNOW WHO THE PHYSICIAN IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957391 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP). HCP REPORTED THAT AFTER MEETING WITH PATIENT THERE WAS NO INDICATION THAT PATIENT EXPERIENCING FULL CONVULSIONS AND BODY TREMORS WAS RELATED TO DEVICE/THERAPY.

  Patient problems: Convulsion/Seizure; Dehydration; Shaking/Tremors; Vertigo

  MAUDE report 22079135 ↗
• MalfunctionMay 13, 2025Failure to Interrogate; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Operating System Becomes Nonfunctional; Failure to Interrogate; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) INITIALLY CALLED AND WAS NOT ABLE TO PROVIDE INFORMATION OTHER THAN HE THOUGHT THAT THE HCP WAS UNABLE TO INTERROGATE THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE CLINICIAN PROGRAMMER. THE REP CALLED BACK AND STATED THAT WHEN THE INS WAS INTERROGATED WITH THE CLINICIAN THERAPY APP, A SYSTEM ERROR MESSAGE WAS DISPLAYED. THE CODE DISPLAYED WITH THE ERROR MESSAGE WAS (B)(6). THE REP INDICATED THAT THEY WERE GOING TO WIPE THE PROGRAMMING AND THEN REPROGRAM THE INS WITH THE CLINICIAN THERAPY APP. THEY CLEARED THE INS WITH A CLINICIAN PROGRAMMER AND THEN REPROGRAMMED THE PATIENT. THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REITERATING THE ISSUE WHERE APP WAS CRASHING AND THE INS NEEDED TO BE READ WITH THE 8840 AND THEN INS NEEDED REPROGRAMMING. THE PATIENT WAS NOT TOLERATING THE SETTINGS AND HAD SOME SIDE AFFECTS. THE HCP WAS SENT THE SETTINGS FROM JUNE, 2021 AND PATIENT WAS PROGRAMMER TO THESE SETTINGS. IT WAS CONFIRMED THAT THEY WERE PROGRAMMER TO CONSTANT VOLTAGE AND NOT CONSTANT CURRENT. SESSION REPORT REVEALED IN RANGE IMPEDANCES.

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

  MAUDE report 22012756 ↗
• MalfunctionMay 13, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS ATTEMPTING TO INTERROGATE THE IMPLANTABLE NEUROSTIMULATOR (INS) MULTIPLE TIMES WITH THE CLINICIAN THERAPY APPLICATION (VERSION 3.0.1062) AND GOT A MESSAGE WITH SYSTEM ERROR 0X4B81F1A3. THE REP INDICATED THAT THE APP FINDS THE INS, DISPLAYS A BLUE SCREEN, AND THEN THE ERROR CODE. THE MESSAGE FORCED THE USER TO END THE SESSION. THE REP HAD ACCESS TO AN 8840 CLINICIAN PROGRAMMER AND WILL ATTEMPT TO INTERROGATE THE INS WITH THE CLINICIAN PROGRAMMER AND THEN WITH THE THERAPY APPLICATION. THE REP CALLED BACK AND STATED THAT THEY CHECKED THE INS WITH ANOTHER TABLET AND GOT A SYSTEM ERROR MESSAGE WITH CODE 0X791EBFE0. AFTER READING THE INS WITH THE TABLET AND RECEIVING THE ERROR CODE, THEY WERE ABLE TO INTERROGATE WITH A CLINICIAN PROGRAMMER TO CLEAR THE ISSUE. THE REP THEN RE-INTERROGATED THE INS WITH THEIR TABLET, WHICH PROMPTED THEM TO UPGRADE THE INS. THIS WAS DONE SUCCESSFULLY AND THE REP WAS ABLE TO ENTER TABLET SESSION TO ENTER INFORMATION AND REPROGRAM THE PATIENT SO THEY WERE GETTING EFFECTIVE THERAPY ON THEIR LEFT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012235 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO REPORTED ABOUT TWO YEARS AGO A WIRE WAS COMING OUT OF THEIR SCALP, SO THE PHYSICIAN REMOVED THE WIRE, AND DIDN¿T REPLACE IT, SO THEY DIDN¿T HAVE ANY SIGNAL GOING TO THEIR RIGHT HAND. THE PATIENT MENTIONED PRIOR TO DISCOVERING THE WIRE WAS COMING OUT OF THEIR SCALP THEY WERE HAVING A LOT OF FALLS.

  Patient problems: Erosion; Fall

  MAUDE report 21401626 ↗
• MalfunctionJan 3, 2025Inappropriate/Inadequate Shock/Stimulation; Low impedance; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT, VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED PRIOR TO BATTERY CHANGE (END OF S ERVICE; NORMAL BATTERY DEPLETION) LEFT BRAIN IMPEDANCES SHOWED LOW ON CONTACT 2 IN BOTH MONOPOLAR AND BIPOLAR. RIGHT BRAIN IMPEDANCES SHOWED LOW ON TACT 9 IN MONOPOLAR AND LOW ON 8,9, AND 11 IN BIPOLAR. THE PATIENT ALSO MENTIONED SLIGHT SHOCKING SENSATIONS MONTHS PRIOR TO THIS. ONCE THE BATTERY WAS REMOVED AND A NEW ONE WAS IMPLANTED ALL IMPEDANCES WERE NORMAL WITH NO ISSUES RESOLVING THE ISSUE.

  Patient problems: Electric Shock

  MAUDE report 21065829 ↗
• MalfunctionOct 16, 2024High impedance; High impedance

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED PRE-OPERATIVE IMPEDANCE ISSUES PRIOR TO ROUTINE BATTERY CHANGE AT CONTACT 8- MONOPOLAR WAS OVER 3,000 OHMS. IT WAS UNKNOWN WHAT LED TO THE ISSUE. DURING SURGERY IMPEDANCES WERE TESTED AT 3V, BUT THE ISSUE WASN¿T RESOLVED WITH THE PATIENT FEELING A SENSATION AT THE LEAD AND CONNECTOR SITE. AFTER THE IMPLANT WAS CHANGED IMPEDANCES WERE TAKEN WITH THE SAME RESULT OF 8- MONOPOLAR GREATER THAN 3,000 OHMS AND BIPOLAR PAIRS 8- 11- AND 8- 10- OVER 4,000 OHMS.

  Patient problems: Insufficient Information

  MAUDE report 20461935 ↗
• MalfunctionAug 26, 2024High impedance; High impedance

  PROVIDER CALLED BECAUSE PATIENT NEEDS MRI AND CONTACTS 8-11 ARE 4391 OHMS AND THERE IS A UNIPOLAR IMPEDANCE OF 3470 OHMS. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064014 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LAST WEDNESDAY THE PATIENT STARTED SHAKING, SO THEY VISITED THEIR MANAGING PROVIDER (HCP) ON THURSDAY FOR AN ADJUSTMENT. AFTER THE ADJUSTMENT, THE PATIENT'S SHAKING GOT WORSE, THEIR SPEECH WAS AFFECTED, AND THEY STARTED FALLING. THE PATIENT CONTACTED THEIR MANAGING HCP, AND THE HCP TOLD THE PATIENT THAT THEY WOULD NEED TO REACH OUT TO THEIR LOCAL MDT REP. THE PATIENT NEVER HEARD BACK FROM THEIR HCP'S OFFICE, WHICH WAS WHY THEY REACHED OUT TO PATIENT SERVICES. AGENT HAD THE PATIENT CHECK THE STATUS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) DURING THE CALL, AND THEY CONFIRMED THE INS BATTERY WAS OK AND THERAPY WAS ON. THE PATIENT REP STATED THAT THE SITUATION WAS ALMOST AN EMERGENCY DUE TO THE PATIENT'S SYMPTOMS. AGENT SENT AN EMAIL TO THE FIELD TO MAKE THEM AWARE OF THE SITUATION AND REQUESTED THAT THEY CONTACT THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PATIENT HAS BEEN HAVING PROBLEMS FOR ABOUT 3 WEEKS AND HAS BEEN IN AND OUT OF THE HOSPITAL. ABOUT THREE WEEKS AGO THE PATIENT MET WITH THE HCP AND THE HCP ADJUSTED THE PATIENT¿S THERAPY, BUT IT DIDN¿T HELP. THEY MET WITH A MEDTRONIC REPRESENTATIVE (REP) ABOUT 2 AND HALF WEEKS AGO A

  Patient problems: Ambulation or Postural Difficulties; Dysphasia; Fall; Shaking/Tremors

  MAUDE report 19959960 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE OPEN WOUND WASN¿T DETERMINED.

  Patient problems: Wound Dehiscence

  MAUDE report 19757039 ↗
• InjuryJun 18, 2024Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) WHO REPORTED THERE WAS A DEFICIENCY IN THE DEVICE PERFORMANCE WITH BATTERY DEPLETION. THE BATTERY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557327 ↗
• MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER FURTHER CLARIFICATION FROM THE NEUROLOGIST, THE NEUROLOGIST CONFIRMED THAT THERE WAS NO MALFUNCTION AND THAT THE REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067111 ↗
• MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER FURTHER CLARIFICATION FROM THE NEUROLOGIST, THE NEUROLOGIST CONFIRMED THAT THERE WAS NO MALFUNCTION AND THAT THE REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19066996 ↗
• MalfunctionMar 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP)  WAS ASKED BY HEALTHCARE PROVIDER (HCP), REGARDING ELECTRICAL LEAKAGE.  CALLER DOES NOT KNOW IF THIS QUESTION WAS RELATED TO A PATIENT. CALLER HAS NO FURTHER DETAILS SURROUNDING THE QUESTION. EMAIL SENT TO REP. REVIEWED ELECTRICAL SHORT. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED PATIENT HAD A FALL MANY YEARS AGO. THE MANUFACTURER REPRESENTATIVE (REP) WAS UNAWARE OF HOW PATIENT WAS WHEN THEY FIRST EXPERIENCED THE LEAKAGE. IMPEDANCES WERE CHECKED ACCORDING TO THE HEALTHCARE PROVIDER (HCP) WHEN THEY LAST SAW THE PATIENT, IMPEDANCES WERE NORMAL. THIS INFORMATION WAS CONFIRMED WITH THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988816 ↗
• MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE LAST CHECK UP, THE PATIENT'S INS BATTERY VOLTAGE LEVEL WAS READ AT 2.86V, AND 2 WEEKS LATER, IT WENT DOWN TO 2.85V. YESTERDAY, THE PATIENT SAW THAT THE VOLTAGE WENT UP TO 2.92V, AND REMAINED AT 2.92V WHEN THEY CHECKED IT TODAY. THE PATIENT INDICATED THAT THE INCREASE IN VOLTAGE WAS NOT SOMETHING THEY EXPECTED, WHICH PROMPTED THE PATIENT TO CALL PS TO CONFIRM WHETHER THE FLUCTUATION WAS NORMAL. THE PATIENT DID CONFIRM THAT THEIR DBS WAS TURNED OFF ON (B)(6) DURING AN APPOINTMENT WITH THEIR NEUROLOGIST FOR BOTOX. THE PATIENT DID NOT INDICATE THAT THERAPY REMAINED OFF SINCE THAT TIME. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983572 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT TURN ON; THE SCREEN WAS DARK AND BLANK DESPITE CHANGING THE BATTERIES TWICE. THE CALLER INSPECTED THE BATTERY COMPARTMENT AND REPORTED IT LOOKED FINE, NO DAMAGE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610044 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PROVIDER CALLED TO GET DEVICE REGISTRATION INFORMATION. THE CALLER STATED THAT THE PATIENT HAD A SYSTEM REVISION. WHEN ASKED FOR ADDITIONAL DETAILS, THE CALLER READ FROM NOTES IN THE MEDICAL RECORD. ON (B)(6) 2023,THE PATIENT HAD REMOVAL OF IMPLANTED NEUROSTIMULATOR (INS) AND WOUND WASH OUT. IN JUNE, THEY PLACED A RIGHT EXTENSION AND RIGHT IPG. THE CALLER INDICATED THAT THERE WAS NOT AN INDICATION OF A PROBLEM WITH THE COMPONENTS OF THE SYSTEM IN THE NOTE AND THE CALLER DID NOT HAVE OTHER INFORMATION ABOUT THE IMPLANTED SYSTEM. THE CALLER WAS NOT WITH THE PATIENT. TROUBLESHOOTING WAS NOT REQUIRED. TECHNICAL SERVICES SPECIALIST REVIEWED INFORMATION FROM REGISTRATION. NO SYMPTOMS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18451445 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INFECTION AT THE BURR HOLE SITE. THE PHYSICIANS INTEND TO REMOVE THE BURR HOLE DEVICE AND THE LEAD.

  Patient problems: Unspecified Infection

  MAUDE report 18443738 ↗
• InjuryJan 4, 2024Low impedance; Adverse Event Without Identified Device or Use Problem; Low impedance; Adverse Event Without Identified Device or Use Problem

  SCHIFF N. D., GIACINO J. T., BUTSON C. R., CHOI E. Y., BAKER J. L., O'SULLIVAN K. P., JANSON A. P., BERGIN M., BRONTE-STEWART H. M., CHUA J., DEGEORGE L., DIKMEN S., FOGARTY A., GERBER L. M., KREL M. MALDONADO J., RADOVAN M., SHAH S. A., SU J., TEMKIN N., TOURDIAS THOMAS., VICTOR J. D., WATERS A., KOLAHOWSKY-HAYNER S. A., FINS J. J., MACHADO A. G., RUTT B. K., HENDERSON J. M. THALAMIC DEEP BRAIN STIMULATION IN TRAUMATIC BRAIN INJURY: A PHASE 1, RANDOMIZED FEASIBILITY STUDY NATURE MEDICINE 2023 DOI: 10.1038/S41591-023-02638-4   ABSTRACT: CONVERGING EVIDENCE INDICATES THAT IMPAIRMENTS IN EXECUTIVE FUNCTION AND INFORMATION-PROCESSING SPEED LIMIT QUALITY OF LIFE AND SOCIAL REENTRY AFTER MODERATE-TO-SEVERE TRAUMATIC BRAIN INJURY (MSTBI). THESE DEFCITS REFECT DYSFUNCTION OF FRONTOSTRIATAL NETWORKS FOR WHICH THE CENTRAL LATERAL (CL) NUCLEUS OF THE THALAMUS IS A CRITICAL NODE. THE PRIMARY OBJECTIVE OF THIS FEASIBILITY STUDY WAS TO TEST THE SAFETY AND EFCACY OF DEEP BRAIN STIMULATION WITHIN THE CL AND THE ASSOCIATED MEDIAL DORSAL TEGMENTAL (CL/DTTM) TRACT. SIX PARTICIPANTS WITH MSTBI, WHO WERE BETWEEN 3 AND 18 YEARS POST-INJURY, UNDERWENT SURGERY WITH ELECTRODE PLACEMENT GUIDED BY IMAGING A

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Fatigue; Headache; Insufficient Information; Paresthesia; Sleep Dysfunction; Syncope/Fainting; Unspecified Infection

  MAUDE report 18443727 ↗
• MalfunctionDec 21, 2023Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THERE WERE NO SPECIFIC SYMPTOMS REPORTED; THE CLINIC WAS GOING TO MONITOR THE PATIENT TO SEE IF DBS THERAPY WAS AFFECTED OR LOSS OF SYMPTOM CONTROL WAS HAPPENING DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380395 ↗
• InjuryOct 3, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT RIGHT AFTER THE SECOND IMPLANT, THE PATIENT GOT AN INFECTION, AND THE DOCTOR MOVED THE IMPLANTABLE NEUROSTIMULATOR INS FROM THE BELLY TO THE SHOULDER *SEE RELATED REPORTED EVENT PE 705831781 INFECTION (2020)*.  THE PATIENT SAID THAT WHEN IMPLANTED IN THE STOMACH, THERE WAS A LONG LEAD, AND WHEN THE DOCTOR MOVED THE INS TO THE SHOULDER, THEY WRAPPED THE EXCESS LEADS AROUND THE DEVICE AND HAD BEEN THAT WAY FOR 3 YEARS NOW, BUT IT IS MUCH MORE UNCOMFORTABLE. THE PATIENT WONDERED WHY THE LEADS COULDN'T JUST BE COILED SEPARATELY AND PLACED TOGETHER ON TOP OF EACH OTHER. THE PATIENT SERVICE SPECIALIST REVIEWED IT WAS THE DOCTOR'S DISCRETION ON HOW THEY HAVE TO DO IT.  WHEN LEADS WERE PLACED AROUND THE DEVICE, ONE SIDE CAUSED THE WIRES TO ARC OUT ON EACH SIDE OF THE DEVICE WHICH JUST TOOK UP MORE SPACE AND WAS TO THE TOUCH, AND THEY COULD FEEL THE RIDGES AND EACH TIME THEY HAD DONE THIS IT WAS A LITTLE SORE. THE PATIENT SAID THAT 'BY WRAPPING A WIRE AROUND ANOTHER ELECTRICAL DEVICE YOU CREATE INDUCTION IN THE COILING'. THE PATIENT WAS SCHEDULED TO HAVE THE IMPLANT REMOVED.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 17858740 ↗
• InjurySep 27, 2023High impedance; Connection Problem; High impedance; Connection Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE HOSPITAL KEPT THE PATIENT OVERNIGHT BECAUSE THEIR TREMOR WAS SO BAD THEY COULDN¿T GO HOME.

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

  MAUDE report 17824892 ↗

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.