DBS™ 3389S-40 (UDI 00763000274405)Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00763000274405), received between Jul 12, 2022 and Sep 28, 2026 — classified as 9 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (35 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. 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 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916621 ↗
• MalfunctionMay 1, 2026Material Deformation

  IT WAS REPORTED THAT LEAD BENDING WAS OBSERVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055751 ↗
• MalfunctionApr 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEAD WAS IDENTIFIED PRIOR TO USE AS HAVING AN ELECTRODE THAT WAS 1 MM SHORTER THAN THE STANDARD LENGTH. THE DEVICE WAS NEVER IMPLANTED. VISUAL INSPECTION AND MEASUREMENT CONFIRMED THE 1 MM SHORTER ELECTRODE. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT-RELATED CONTRIBUTING FACTORS WERE REPORTED. THE PRODUCT WAS COLLECTED AND RETURNED, AND THE ISSUE WAS REPORTED AS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048701 ↗
• MalfunctionApr 14, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, ABNORMALLY HIGH LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS NEVER IMPL ANTED. THE LEAD WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24878392 ↗
• MalfunctionApr 13, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD LOCK COULD NOT BE ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858653 ↗
• MalfunctionApr 6, 2026High impedance; Impedance Problem

  ADDITIONAL INFORMATION CLARIFIED THAT THE IMPEDANCES WERE HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794336 ↗
• MalfunctionApr 6, 2026Low impedance

  IT WAS REPORTED THAT THE LEAD WAS IDENTIFIED AS HAVING AN ELECTRODE FAILURE DURING A DEEP BRAIN STIMULATION PROCEDURE WHEN IMPEDANCE TESTING DID NOT PASS AND INDICATED A SHORT CIRCUIT. THE LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791759 ↗
• MalfunctionMar 30, 2026Break; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). MANUFACTURING REPRESENTATIVE REPORTED THAT THE LEAD WAS BENT UPON OPENING THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734714 ↗
• MalfunctionMar 30, 2026Break; High impedance

  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 24724047 ↗
• MalfunctionMar 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD EXPERIENCED A MALFUNCTION AS THE LOCKING MECHANISM COULD NOT BE ENGAGED. THE DEVICE WAS REPLACED ON THE SAME DAY, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551996 ↗
• MalfunctionMar 5, 2026High impedance

  IT WAS REPORTED THAT THE LEAD RESISTANCE WAS OBSERVED DURING THE PROCEDURE. THE SURGERY WAS COMPLETED THE SAME DAY AND THE ISSUE WAS RESOLVED. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521055 ↗
• MalfunctionJan 26, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD EXHIBITED EXCESSIVE ELECTRIC RESISTANCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184246 ↗
• MalfunctionJan 22, 2026High impedance

  IT WAS REPORTED THAT THE LEAD IMPEDANCE WAS TOO HIGH. THE LEAD WAS NEVER IMPLANTED AND IT 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 24148181 ↗
• MalfunctionJan 19, 2026Impedance Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD EXHIBITED ABNORMAL IMPEDANCE. THE LEAD WAS NEVER IMPLANTED AND IT WAS REPLACED ON THE SAME DAY TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111325 ↗
• MalfunctionJan 14, 2026Break; Material Twisted/Bent

  ADDITIONAL INFORMATION CLARIFIED THAT THE ISSUE OCCURRED OUT OF BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073363 ↗
• MalfunctionDec 19, 2025Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED THAT THE LEAD SHOWED A BEND AT THE TIP AND THE LEAD LOCKING CAP COULD NOT BE SECURED PRIOR TO IMPLANTATION. THE DEVICE WAS NEVER IMPLANTED AND NO SURGICAL INTERVENTION OCCURRED OR IS PLANNED. A REPLACEMENT WAS USED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854480 ↗
• MalfunctionDec 18, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE LEAD EXHIBITED FAULTY RESISTANCE AND FAILED THE CONNECTION TEST PRIOR TO IMPLANTATION. A REPLACEMENT WAS PROVIDED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844849 ↗
• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE LEAD TIP WAS FOUND TO BE BENT OUT OF BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790315 ↗
• MalfunctionDec 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD EXHIBITED EXCESSIVE ELECTRIC RESISTANCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780318 ↗
• MalfunctionDec 1, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE LEAD EXPERIENCED A MALFUNCTION, AS THE LOCKING CAP COULD NOT BE LOCKED PRIOR TO IMPLANTATION. THE DEVICE WAS NEVER IMPLANTED. A REPLACEMENT WAS PROVIDED 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 23682096 ↗
• MalfunctionNov 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS DETECTED DURING THE DEEP BRAIN STIMULATION PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE LEADS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638652 ↗
• MalfunctionNov 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS DETECTED DURING THE DEEP BRAIN STIMULATION PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE LEADS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571231 ↗
• MalfunctionOct 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE TIP OF THE LEAD WAS FOUND TO BE KINKED. THE AFFECTED LEAD WAS REPLACED DURING THE SAME PROCEDURE, AND THE SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368390 ↗
• MalfunctionOct 23, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE ISSUE WAS FOUND OUT OF BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368367 ↗
• MalfunctionOct 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH IMPEDANCE IN A PATIENT UNDERGOING DEEP BRAIN STIMULATION SURGERY. NO DIAGNOSTICS OR TRO UBLESHOOTING WERE PERFORMED. THE ISSUE 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 23337375 ↗

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.