N/A 3708660Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00763000236830), received between Mar 5, 2020 and Jun 22, 2026 — classified as 7 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXTENSION WAS RETURNED WITH NO ALLEGATIONS; HOWEVER, ANALYSIS IDENTIFIED AN ANOMALY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585581 ↗
• MalfunctionJun 3, 2026High impedance

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE DEEP BRAIN STIMULATION PROCEDURE, HIGH EXTENSION RESISTANCE WAS DETECTED ON AN INTRAOPERATIVE RESISTANCE CHECK. THE EXTENSION LEAD WAS REPLACED THE SAME DAY TO COMPLETE THE SURGERY, AND THE ISSUE WAS REPORTED AS RESOLVED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376052 ↗
• MalfunctionMay 18, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) HAS AN EXTENSION STILL IN THE BOX THAT WAS TEXTED TO HER FROM A COLLEAGUE. THE CALLER STATES THE PACKAGE OF THE EXTENSION WAS FRACTURED/DAMAGED SO SHE HAS ELECTED TO NOT USE IT AND SEND IT BACK. THE CALLER DID NOT OPEN THE BOX ITSELF. CALLER WILL SEND PRODUCT BACK. NO PATIENT (PT) OR HEALTHCARE PROVIDER (HCP) ASSOCIATED WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210604 ↗
• MalfunctionApr 28, 2026Material Deformation

  IT WAS REPORTED THAT THE EXTENSIONS WERE NOTED INTRAOPERATIVELY TO BE BENT. THE EXTENSIONS WERE REPLACED WITH NEW EXTENSIONS ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020902 ↗
• MalfunctionApr 28, 2026Material Deformation

  IT WAS REPORTED THAT THE EXTENSIONS WERE NOTED INTRAOPERATIVELY TO BE BENT. THE EXTENSIONS WERE REPLACED WITH NEW EXTENSIONS ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020889 ↗
• MalfunctionApr 24, 2026Break; Material Deformation

  IT WAS REPORTED THAT EXTENSION KINKING WAS IDENTIFIED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980647 ↗
• MalfunctionApr 24, 2026Connection Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE SCREW INSIDE THE EXTENSION WAS LOOSE AND COULD NOT BE TIGHTENED TO CONNECT THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980627 ↗
• MalfunctionApr 24, 2026Break; Material Deformation

  IT WAS REPORTED THAT EXTENSION KINKING WAS IDENTIFIED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980602 ↗
• MalfunctionApr 21, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION EXHIBITED A MALFUNCTION, WITH IMPEDANCE TESTING REVEALING ABNORMALLY HIGH IMPEDANCE. THE EXTENSION WAS NEVER IMPLANTED. A NEW EXTENSION WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942249 ↗
• MalfunctionApr 20, 2026High impedance

  IT WAS REPORTED THAT, PRIOR TO USE, A LEAD IMPEDANCE WAS REPORTED TO BE TOO HIGH. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. A GUARANTEED REPLACEMENT WAS PROVIDED, AND THE ISSUE WAS REPORTED AS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932123 ↗
• MalfunctionMar 30, 2026High impedance

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE DEEP BRAIN STIMULATION PROCEDURE, HIGH EXTENSION RESISTANCE WAS DETECTED ON AN INTRAOPERATIVE RESISTANCE CHECK. THE EXTENSION LEAD WAS REPLACED THE SAME DAY TO COMPLETE THE SURGERY, AND THE ISSUE WAS REPORTED AS RESOLVED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731610 ↗
• MalfunctionMar 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT INTRAOPERATIVELY A LEAD FRACTURE WAS IDENTIFIED, RESULTING IN EXCESSIVELY HIGH ELECTRIC RESISTANCE AND AN OPEN CIRCUIT. MANUFACTURING REPRESENTATIVE REPORTED THAT THERE WAS DAMAGE TO THE SCREW OF THE EXTENSION AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724830 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS A LEAD THAT IS EXPOSED AT THE INCISION SITE, LATER STATING IT IS STILL IN THE BODY, BUT STATES IT IS EXPOSED TO AIR. TECH SERVICES REVIEWED MRI LABELING; HOWEVER, REP REQUESTED AN ENGINEER CONTACT THEM AS SOON AS POSSIBLE. REP STATES THE PHYSICIAN WANTS TO PULL THE WIRES AND CUT THEM, BUT THE PATIENT HAS AN MRI SCHEDULED TOMORROW. REP WAS UNSURE WHEN THIS BEGAN. REP STATED THE IMPEDANCES WERE NORMAL LAST TIME HE MET WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING ON 1/22/26, THE LEAD AND EXTENSION WERE EXPLANTED, AND A PLUG WAS PLACED IN THE IMPLANT. THE OPEN WOUND WAS CLOSED BUT THE PATIENT HAS TO WAIT 3 MONTHS TO GET IMPLANTED. REP CLARIFIES THAT THE CONNECTION POINT BETWEEN THE LEAD AND EXTENSION ON THE LEFT SIDE OF THE PATIENT'S HEAD BEHIND THE EAR IS THE LOCATION OF THE EROSION. THE DEVICES HAVE NOT MIGRATED FROM THEIR IMPLANTED POSITION.

  Patient problems: Erosion

  MAUDE report 24316414 ↗
• MalfunctionJan 30, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION EXHIBITED A MALFUNCTION, WITH IMPEDANCE TESTING REVEALING ABNORMALLY HIGH IMPEDANCE. THE EXTENSION WAS NEVER IMPLANTED. A NEW EXTENSION WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223077 ↗
• MalfunctionJan 2, 2026High impedance

  IT WAS REPORTED THAT THE EXTENSIONS RESISTANCE IS TOO HIGH SO IT WAS NEVER IMPLANTED AND ANOTHER EXTENSION WAS USED. THE ISSUE WAS SAID TO BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944615 ↗
• MalfunctionDec 1, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE INNER PACKAGING OF THE EXTENSION WAS FOUND TO BE DAMAGED. THE EXTENSION WAS NEVER IMPLANTED AND IT WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682485 ↗
• MalfunctionNov 13, 2025Break; Connection Problem; Insufficient Device Problem Information; Break; Connection Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SCREW LOCK SLIPPERY THREAD WAS DISCOVERED DURING THE SURGERY. THE DEVICE WAS NEVER IMPLANTED. THEY REPLACED THE EXTENSION ON THE SAME DAY TO COMPLETE THE SURGERY. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547441 ↗
• MalfunctionAug 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING DEEP BRAIN STIMULATION SURGERY, THE EXTENSION IMPEDANCE WAS DISCOVERED TO BE TOO HIGH. THE EXTENSION WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922528 ↗
• MalfunctionJul 10, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, AN EXTENSION FAILURE OCCURRED, AS THE SCREW CONNECTING THE LEAD WAS FALLING OFF. THE DEVICE WAS NEVER IMPLANTED AND THE EXTENSION WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469897 ↗
• MalfunctionMar 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE ELECTRIC RESISTANCE OF THE EXTENSION WAS FOUND TO BE TOO HIGH. THE POSSIBLE CONTRIBUTING FACTORS WERE UNKNOWN. THE EXTENSION WAS NEVER IMPLANTED AND IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643127 ↗
• MalfunctionMar 13, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THERE WAS AN EXTENSION FAILURE AND ABNORMAL ELECTRIC RESISTANCE IN A DEEP BRAIN STIMULATION DEVICE. THE EXTENSION WAS NEVER IMPLANTED, AND NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE ISSUE WAS RESOLVED WITH A REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594251 ↗
• InjuryJan 24, 2025Break; Inappropriate/Inadequate Shock/Stimulation; Break; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF ESSENTIAL TREMORS EXPERIENCED A SHOCKING SENSATION ON THE LEFT SIDE, SPECIFICALLY AFFECTING THE TONGUE AND LEFT SIDE OF THE HEAD, RELATED TO THE DEEP BRAIN STIMULATION SYSTEM. A BREAK IN THE INSULATION OF THE LEFT NECK EXTENSION WAS IDENTIFIED. IMPEDANCE TESTING WAS CONDUCTED AND FOUND TO BE NORMAL, AND X-RAYS SHOWED NO VISUAL CHANGES TO THE SYSTEM. DURING A SURGICAL INTERVENTION, THE LEFT EXTENSION AND BATTERY WERE REPLACED. THE PATIENT REPORTED THAT THE SHOCKING SENSATION RESOLVED POSTOPERATIVELY.

  Patient problems: Electric Shock

  MAUDE report 21231263 ↗
• MalfunctionDec 11, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION IMPEDANCE WAS TOO HIGH, NECESSITATING THE REPLACEMENT OF THE EXTENSION TO COMPLETE THE SURGERY. THE ISSUE WAS IDENTIFIED INTRAOPERATIVELY, WITH THE EXTENSION NOT HAVING BEEN IMPLANTED YET, AND THE SURGERY WAS SUCCESSFULLY COMPLETED ON THE SAME DAY WITH THE NEW EXTENSION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903862 ↗
• InjuryNov 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION WIRE FOR THE DEVICE EXHIBITED HIGH IMPEDANCE. THIS ISSUE WAS IDENTIFIED INTRAOPERATIVELY. AS A RESULT, THE EXTENSION WIRE WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THE ISSUE RESOLVED WITH THE REPLACEMENT OF THE WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779586 ↗
• InjuryJul 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, ONE END OF THE EXTENSION WAS FOUND TO BE BENT AND COULD NOT BE USED NORMALLY. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792462 ↗

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.