DBS ™ 3387S-40 (UDI 00643169313514)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169313514), received between Dec 19, 2016 and Sep 17, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Bent” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Break; High impedance; Low impedance; Material Deformation; Break; High impedance; Low impedance; Material Deformation

  IT IS BEING REPORTED THAT THE PATIENT¿S RIGHT BRAIN LEAD WAS VISIBLY FRACTURED. THIS WAS DETERMINED DURING INTEROPERATIVE EXAMINATION AND TESTING OF IMPEDANCE VALUES. IMPEDANCES WERE CHECKED, PRE-PROCEDURE AND FOUND TO BE ABNORMAL. PATIENT HAD REPORTED LOSS OF SYMPTOM CONTROL APPROXIMATELY ONE MONTH AGO. EXACT DATE IS UNKNOWN. PATIENT STARTED EXPERIENCING SIGNIFICANT TREMOR ON THE LEFT SIDE OF HIS BODY THAT WAS NOT RESOLVED BY CHANGING PROGRAMMING. X-RAYS WERE TAKEN AND A NOTICEABLE BEND/KINK IN THE RIGHT BRAIN LEAD WAS VISIBLE. SURGICAL INTERVENTION WAS OPTED FOR TO EXAMINE THE RIGHT BRAIN LEAD AND TEST INTEROPERATIVE IMPEDANCES. UPON TESTING THE RIGHT BRAIN LEAD IMPEDANCES WERE ABNORMAL ON ALL ELECTRODES. ISSUE IS NOT RESOLVED AT TIME OF THIS REPORT. IT IS UNDETERMINED IF THIS TIME IF THE RIGHT BRAIN LEAD WILL BE REPLACED IN THE FUTURE. IT IS ALSO UNDETERMINED IF THE PATIENT IS A SURGICAL CANDIDATE FOR ANOTHER LEAD REPLACEMENT.

  Patient problems: Shaking/Tremors

  MAUDE report 23072779 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR EXPERIENCED A WOUND OVER THE LEAD ON THEIR HEAD. THE WOUND INITIALLY HEALED BUT SUBSEQUENTLY REOPENED, EXPOSING APPROXIMATELY 0.5 INCH OF THE WIRE ON TOP OF THE SCALP. A MINOR INFECTION DEVELOPED, WHICH WAS TREATED WITH ANTIBIOTICS AND DRAINAGE. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR FURTHER CONSULTATION DUE TO CONCERNS ABOUT POTENTIAL COMPLICATIONS, SUCH AS BOWSTRINGING.

  Patient problems: Erosion; Fluid Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 21218571 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN INFECTION ALONG THE LOCATION OF THE LEAD IMPLANT IN THE HEAD. THERE WERE NO FACTORS THAT LED TO THE INFECTION. THE LEAD WAS SURGICALLY REMOVED WHERE THE INFECTION WAS LOCATED. THE EXTENSION WIRE WAS LEFT CAPPED AND IMPLANTED. THE ISSUE WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 11797026 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SET TO HAVE STAGE I IMPLANTATION OF NEW BRAIN ELECTRODE FOR RIGHT HEMISPHERE. IT WAS DISCOVERED AS PATIENT WAS BEING PREPPED FOR SURGERY THAT EROSION HAD OCCURRED OVER HER EXISTING LEFT BRAIN ELECTRODE. THE PHYSICIAN DISCUSSED THE ISSUE WITH PATIENT AND CANCELED THE RIGHT LEAD IMPLANTATION BECAUSE OF SKIN EROSION AND WAS CONCERNED THAT HER EXISTING HARDWARE COULD BE INFECTED BECAUSE OF THE EROSION. THERE WAS PLANS ON REMOVING THE PATIENT'S LEFT BRAIN LEAD SOMETIME NEXT WEEK. PLASTIC SURGERY WILL ASSIST WITH SKIN CLOSURE AFTER LEAD HAS BEEN EXPLANTED. IT WAS NOT DETERMINED IF LEFT EXTENSION AND IPG WILL BE REMOVED ALONG WITH THE LEFT BRAIN LEAD.

  Patient problems: Erosion; Skin Erosion

  MAUDE report 11453082 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTED SCALP WOUND AT THE LEFT ELECTRODE SITE FOLLOWING THE IMPLANTATION PROCEDURE ON (B)(6) 2014. THE DIAGNOSTIC METHODS INCLUDED A SURGICAL OBSERVATION ON (B)(6) 2014 WHICH RESULTED IN THE IDENTIFICATION OF THE EVENT. THE ETIOLOGY WAS NOTED AS RELATED TO THE DEVICE/THERAPY AND RELATED TO THE IMPLANT PROCEDURE; SURGERY/ANESTHESIA WERE NOTED. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE INCLUDED ADMINISTERING ANTIBIOTICS ON (B)(6) 2014. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Injury; Post Operative Wound Infection

  MAUDE report 7041295 ↗
• MalfunctionFeb 17, 2017Bent; Bent

  A HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE LEAD END LOOKED CRIMPED AFTER REMOVING THE LEAD END CAP ON THE DATE OF IMPLANT, (B)(6). IT WAS STATED THAT THE LEAD END CAP SET SCREW MAY HAVE NOT BEEN COVERING THE METAL CONTACT WHEN TIGHTENED, POTENTIALLY CAUSING THE ISSUE. THE LEAD WAS STILL PUT INTO THE EXTENSIONS AND IMPEDANCES WERE CHECKED WHICH SHOWED AS NORMAL. NO ACTIONS OR INTERVENTIONS WERE TAKEN AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6339954 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAD RESPIRATORY ARREST DURING SET UP FOR THE PROCEDURE DUE TO ANESTHESIA GIVING TOO MUCH SEDATION. NO INCISION HAD BEEN MADE AND NO IMPLANTS OR EQUIPMENT HAD BEEN OPENED. THE SEDATION WAS REVERSED AND THE PATIENT STARTED BREATHING NORMALLY, WITH THE PROCEDURE COMPLETED SUCCESSFULLY AND THE ISSUE RESOLVED WITH NO CODE NECESSARY. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

  Patient problems: Respiratory Failure

  MAUDE report 6242266 ↗
• MalfunctionDec 19, 2016Bent; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Bent; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected

  A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THEY WERE DOING A NEW IMPLANT ON (B)(6) AND THE LEAD TIP, SPECIFICALLY THE SILICONE PIECE DISTAL TO 0 CONTACT, APPEARED CROOKED/BENT OUT OF THE BOX. IT WAS STATED THAT IT DIDN'T LOOK LIKE OTHER LEADS AND A DIFFERENT LEAD THAT LOOKED "NORMAL" WAS USED. IT WAS FURTHER NOTED THAT DURING THE CASE THEY ALSO HAD A DEFECTIVE STIM-LOC IN WHICH THE TITANIUM SCREW WAS STRIPPED, WHICH "HAPPENS A LOT" AND THE SURGEON HAS SEEN SEVERAL TIMES. A DIFFERENT KIT WITH A NEW SCREW WAS USED AS WELL. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6185349 ↗

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.