DBS™ 3387S-40 (UDI 00763000274320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000274320), received between Mar 20, 2023 and Apr 7, 2026 — classified as 10 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier.

19 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 27, 2022Completed

   There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

   Z-0217-2024 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break; Material Deformation

  IT WAS REPORTED THAT, PRIOR TO IMPLANTATION DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD WAS NOTED TO BE BENT. THE LEAD WAS R EPLACED 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 24807136 ↗
• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT THE LEAD GUIDEWIRE COULD NOT BE PULLED OUT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792504 ↗
• MalfunctionJan 14, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, LEAD BENDING WAS DISCOVERED. THE LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE PROCEDURE. NO SURGICAL INTERVENTION WAS REQUIRED BEYOND THE REPLACEMENT OF THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070346 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD CONTACT WAS FOUND TO BE KINKED. THE KINKED LEAD WAS REPLACED DURING THE SAME PROCEDURE, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597928 ↗
• InjuryNov 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT THEY DISCOVERED LEAD WAS SHOWING HIGH IMPEDANCES ON CONTACT 1, SURGICAL INTERVENTION OCCURRED IN ORDER TO ASSESS WHERE IT WAS COMING FROM. FIRST, STIMULATION WAS PROVIDED PRIOR TO SURGERY IN ORDER TO ATTEMPT TO PREVENT SURGICAL INTERVENTION THROUGH RUNNING CURRENT THROUGH CONTACT. THIS DID NOT FIX THE ISSUE, THE BATTERY POCKET/EXTENSION WERE UNPLUGGED AND PUT BACK INTO PORT AFTER BEING CLEANED, THIS DID NOT FIX THE ISSUE. THEN, THE EXTENSION AND LEAD END WERE DISCONNECTED IN ORDER TO ASSESS WHERE THE PROBLEM WAS. THE LEAD WAS DETERMINED TO BE THE PROBLEM, AND WAS REPLACED BY NEW LEAD AND NEW EXTENSION (COMPATIBLE WITH NEW LEAD) FOR PATIENT'S LEFT SIDE OF BODY/BATTERY. ISSUE HAS BEEN RESOLVED. NO EXTERNAL FACTORS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532818 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH PARKINSON'S DISEASE UNDERWENT DEEP BRAIN STIMULATION SURGERY AND SUBSEQUENTLY DEVELOPED A POSTOPERATIVE INFECTION AT THE LEAD SITE. NO TESTING OR IMAGING WAS CONDUCTED. REPLACEMENT SURGERY IS SCHEDULED FOR (B)(6) 2025. THE ISSUE WAS REPORTED AS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23367530 ↗
• MalfunctionSep 19, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD TIP WAS DISCOVERED TO BE BENT. INTRAOPERATIVE OBSERVATION CONFIRMED THE LEAD TIP DEFORMATION, INDICATING DEVICE MALFUNCTION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH REPLACEMENT OF A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099838 ↗
• MalfunctionAug 21, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DEEP BRAN STIMULATION OPERATION, IT WAS FOUND THAT THE ELECTRODE TIP WAS BENT. IT WAS NOT BENT OUT OF BOX. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH THE NEW ELECTRODE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865874 ↗
• MalfunctionAug 6, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD WAS FOUND TO HAVE EXCESSIVELY HIGH IMPEDANCES. THE AFFECTED LEAD WAS NEVER IMPLANTED, AND A NEW LEAD OF THE SAME TYPE WAS USED TO COMPLETE THE SURGERY 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 22726216 ↗
• MalfunctionMay 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION OPERATION, THE FRONT END OF THE LEAD CONTACT WAS FOUND TO BE FAULTY. THE LEAD WAS REPLACED ON THE SAME DAY, AND THE OPERATION WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084671 ↗
• MalfunctionMay 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER CONFIRMATION IT WAS FOUND THAT THE ELECTRODE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941937 ↗
• InjuryMar 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF PARKINSON'S DISEASE EXPERIENCED A LEAD FAILURE. THE ISSUE WAS IDENTIFIED AS HIGH ELECTRIC RESISTANCE IN THE PATIENT'S LEAD AFTER THE OPERATION. THE LEAD WAS SUBSEQUENTLY EXPLANTED, AND ELECTIVE SURGERY WAS PLANNED FOR A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677274 ↗
• MalfunctionFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN THE SURGEON REMOVED THE ELECTRODE FROM THE STERILE BOX, THEY FOUND THAT ONE OF THE ELECTRODE HAD A SMALLER POLE SPACING. THERE WAS NO SPARE ELECTRODE IN THE OPERATING ROOM, SO THE POSSIBILITY OF REPLACING THE PART WAS OFFERED. HOWEVER, THE LOGISTICAL PROCESS UNTIL THE NEW PART ARRIVED WOULD TAKE APPROXIMATELY 90 MINUTES. CONSIDERING THE PATIENT HAD SKULL TREPHINATION PERFORMED, THE SURGEON DID NOT CONSIDER IT SAFE FOR THE PATIENT TO WAIT SO LONG AND CHOSE TO IMPLANT THE ELECTRODE, EVEN THOUGH IT WAS NON-COMPLIANT. THE PATIENT ALSO HAD ANOTHER WITH A LARGER SPACING IMPLANTED, THOUGH THE OBJECTIVE WAS IMPLANTING TWO ELECTRODES WITH LARGER SPACING (1.5MM SPACING). VISUAL ANALYSIS AND IMPEDANCE TESTING WERE CARRIED OUT, AND IT WAS FOUND THAT THERE WAS CONTINUITY IN ALL SEGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455131 ↗
• InjuryDec 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT AFTER A DEEP BRAIN STIMULATION PROCEDURE, THE PATIENT'S LEAD CIRCUIT WAS FOUND TO BE DISCONNECTED. THE OPERATION WAS PERFORMED AGAIN ON (B)(6) 2024, TO REPLACE THE LEAD 3387S-40. THE ISSUE WAS RESOLVED WITH THE REPLACEMENT OF THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018710 ↗
• MalfunctionOct 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT DURING THE OPERATION. THE LEAD WAS NEVER IMPLANTED. THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515194 ↗
• MalfunctionAug 21, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE LEAD'S TIP WAS FOUND TO BE BENT DURING SURGERY. THE LEAD WAS NEVER IMPLANTED. THE LEAD WAS REPLACED WITH A NEW LEAD ON THE SAME DAY. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016348 ↗
• InjuryAug 12, 2024Break; Break

  IT WAS REPORTED THAT THE LEAD LOCK AND SCREWS WERE BROKEN DURING THE PATIENT'S SURGERY. THE LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION AND THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961686 ↗
• InjuryJul 15, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE OPERATION, THE STIMLOC LEAD CLAMP WAS FOUND TO HAVE CRACKS AND WAS NOT FIXED FIRMLY. THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744897 ↗
• InjuryJul 5, 2024Device Contamination with Chemical or Other Material; Human-Device Interface Problem; Device Contamination with Chemical or Other Material; Human-Device Interface Problem

  IT WAS REPORTED THAT WATER WAS FOUND LEAKING FROM THE TIP OF THE LEAD DURING SURGERY. A NEW LEAD WAS REPLACED ON THE SAME DAY AND THE OPERATION WAS COMPLETED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681988 ↗
• InjuryJun 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT DURING SURGERY. NO SYMPTOMS REPORTED. A REPLACEMENT WAS USED TO COMPLETE THE SURGERY AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448331 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT THE FIXING SCREW OF THE LEAD STIMLOC BASE RING WAS BROKEN DURING SURGERY. UNKNOWN WHAT FACTORS LED TO THE ISSUE. THE STIMLOC WAS REPLACED SAME DAY TO COMPLETE SURGERY AND THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280428 ↗
• MalfunctionMar 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT DURING THE OPERATION. A NEW LEAD WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887630 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SMALL BULGE AT THE SITE WHERE THE LEAD WAS IMPLANTED ON THE PATIENT'S HEAD. THE DOCTOR INITIALLY DIAGNOSED THAT THERE MIGHT BE FLUID ACCUMULATION AND FURTHER OBSERVATION WAS NEEDED. IN THE PAST FEW DAYS, IT WAS FOUND THAT THE CONDITION OF THE SMALL BULGE HAS IMPROVED AND THE PATIENT DIDN'T FEEL ANY DISCOMFORT. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE PATIENT WAS HOSPITALIZED DUE TO THE FLUID BUILD UP.

  Patient problems: Seroma

  MAUDE report 18631217 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD IMPLANTATION SITE ON THE PATIENT'S HEAD. IT IS UNKNOWN IF THE ISSUE IS RESOLVED, BUT THE LEAD IS STILL IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE PATIENT HAS RECENTLY BEEN REPLACED WITH NEW ELECTRODES TO SOLVE THE PROBLEM OF INFECTION. THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 18630895 ↗
• MalfunctionNov 21, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DISTRIBUTOR CALLED TO INFORM THAT THE LEAD 3387S-40 WAS BENT DURING THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH NEW LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185354 ↗

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-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-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
• Z-0185-2009 · Jun 14, 2008 · Terminated
  Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide

…and 4 more.