DBS™ 3387S-40 (UDI 00643169752290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 00643169752290), received between Jun 9, 2017 and Jan 12, 2026 — classified as 58 injuries, 97 malfunctions.

The most frequently reported specific device problem is “High impedance” (29 reports).

20 other recalls cover devices cleared under the same FDA submission (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 155 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT THE PATIENT HAD SUSPECTED DAMAGED CRANIAL DBS LEADS. HCP EXPOSED THE DISTAL END OF THE LEADS WHICH AND DISCOVERED THAT THE CONTACTS AND INSULATION WERE STRIPPED OFF OF THE LEADS. DUE TO THE EXTREME CONDITION OF THE LEADS THERE WAS NO WAY TO TROUBLESHOOT. VISUAL INSPECTION WAS SUFFICIENT TO CONCLUDE THAT THE LEADS WERE IRREVOCABLY DAMAGED. THE SECTION OF THE CRANIAL LEADS THAT CONNECT TO THE EXTENSION WIRE (DISTAL END) WERE STRIPPED DOWN TO BARE WIRE AT A DIFFERENT FACILITY BY A DIFFERENT PHYSICIAN. HE THEN REMOVED THE PORTION OF THE LEADS WHICH WERE OUTSIDE THE CRANIUM IN ANTICIPATION OF RETURNING TO REVISE THE LEADS COMPLETELY AT A LATER DATE ((B)(6) 2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036433 ↗
• MalfunctionNov 8, 2024Break; High impedance; Insufficient Device Problem Information; Break; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY HAD DIFFICULTY WITH THE WIRE SINCE IT WAS PUT IN RELATED TO PROGRAMMING. THE PATIENT DIDN'T KNOW IF IT WAS BROKE BEFORE THE LAST SURGERY OR BROKE DURING THE UPGRADE REPLACEMENT IN NOVEMBER. WHEN THEY REPLACED THE BATTERY THEY FOUND AN OPEN IMPEDANCE ON THE LEFT WHICH CONTROLLED THE RIGHT SIDE. THE PATIENT DIDN'T KNOW WHY THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640785 ↗
• MalfunctionMar 21, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD WAS FOUND TO HAVE HIGH RESISTANCE DURING SURGERY. THE LEAD WAS REPLACED TO COMPLETE THE SURGERY. THE PATIENT WAS IN THE HOSPITAL FOR OBSERVATION AFTER THE SURGERY. THE CAUSE OF THE ISSUE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951366 ↗
• MalfunctionMar 21, 2024High impedance; High impedance

  IT WAS REPORTED THE LEAD WAS FOUND TO HAVE HIGH RESISTANCE AND COULD NOT BE USED NORMALLY. THE LEAD WAS REPLACED WITH A DIFFERENT LEAD DURING SURGERY, WHICH RESOLVED THE ISSUE. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951072 ↗
• MalfunctionNov 9, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE DOCTOR OPENED THE BOX TO PREPARE THE DBS LEAD IMPLANTATION, THEY SAW THAT THE LEAD TIP WAS CURVED. THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. A NEW ELECTRODE WAS OPENED. THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107251 ↗
• InjuryJul 13, 2023Break; Low impedance; Insufficient Device Problem Information; Break; Low impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE PATIENT HAD NOT BEEN SCHEDULED FOR SURGERY YET; THERE WAS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320629 ↗
• MalfunctionMar 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TIP OF THE LEAD WAS FOUND TO BE BENT DURING SURGERY AND IT HAD BEEN REPLACED WITH A NEW LEAD THE SAME DAY TO COMPLETE SURGERY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691065 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS WERE EXPOSED BUT THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE HAIR COVERED THE EXPOSURE SO THE PATIENT DID NOT KNOW IT WAS VISIBLE. THE FACTORS THAT MAY HAVE LED TO THIS ISSUE WAS THE REP WAS TOLD THE PATIENT'S SCALP IS VERY THIN. THE LEADS AND EXTENSIONS WERE EXPLANTED AND REPLACED. THE ISSUE WAS RESOLVED.

  Patient problems: Erosion

  MAUDE report 13334146 ↗
• MalfunctionNov 7, 2021Break; Low impedance; Activation, Positioning or Separation Problem; Break; Low impedance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT YESTERDAY THE DOCTOR HAD TROUBLE TUNNELING AND MAY HAVE DAMAGED THE LEAD BECAUSE IT CAME UP AT SHORTED 01. THEY RECONNECTED AT THE INS AND LEAD AND ALSO THE LEAD AND EXTENSION WITH NO CHANGE. THE DOCTOR REPORTED HE THOUGHT HE WAS SHEARING THE ELECTRODE AT THE LEAD/EXTENSION CONNECTION SO HE LEFT IT ALONE. PATIENT WEIGHT IS (B)(6) LBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762162 ↗
• MalfunctionNov 7, 2021Break; Low impedance; Activation, Positioning or Separation Problem; Break; Low impedance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT YESTERDAY THE DOCTOR HAD TROUBLE TUNNELING AND MAY HAVE DAMAGED THE LEAD BECAUSE IT CAME UP AT SHORTED 01. THEY RECONNECTED AT THE INS AND LEAD AND ALSO THE LEAD AND EXTENSION WITH NO CHANGE. THE DOCTOR REPORTED HE THOUGHT HE WAS SHEARING THE ELECTRODE AT THE LEAD/EXTENSION CONNECTION SO HE LEFT IT ALONE. PATIENT WEIGHT IS (B)(6) LBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762093 ↗
• InjuryAug 6, 2021High impedance; High impedance

  IT WAS REPORTED THAT DURING THE OPERATION THERE WERE TWO LEADS THAT WERE FOUND TO HAVE HIGH RESISTANCE AND COULDN'T BE USED NORMALLY. THE LEADS WERE REPLACED ON THE SAME DAY AND THE OPERATION WAS COMPLETED. THE PATIENT WAS CURRENTLY IN THE HOSPITAL FOR OBSERVATION AND THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287844 ↗
• MalfunctionAug 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE LEAD WAS BENT AND COULD NOT BE USED NORMALLY. THE LEAD WAS REPLACED AND SURGERY WAS COMPLETED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285612 ↗
• MalfunctionJul 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY, THE LEAD TIP WAS BENT AND COULD NOT BE USED NORMALLY. A NEW LEAD WAS UTILIZED AND THE SURGERY WAS COMPLETE. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CAUSE OF THE ISSUE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229649 ↗
• MalfunctionJul 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED WHEN REMOVING THE LEAD FROM THE INTERNAL PACKAGE PRIOR TO STARTING A CASE THEY NOTICED THE LEAD TIP WAS BENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGE OF THE DEVICE. THE DEVICE WASN¿T USED, BUT RATHER ANOTHER LEAD WAS OPENED WITH NO ISSUE RESOLVING THE PROBLEM.

  Patient problems: Pulmonary Dysfunction

  MAUDE report 12127551 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPEECH ISSUES AND WAS ADMITTED TO HOSPITAL.

  Patient problems: Dysphasia

  MAUDE report 12059393 ↗
• InjuryJun 22, 2021Migration or Expulsion of Device; Difficult to Open or Close; Migration or Expulsion of Device; Difficult to Open or Close

  IT WAS REPORTED THAT THE STIMLOC WAS DIFFICULT TO CLOSE AND WOULDN¿T FULLY ENGAGE. THEN AT THE END OF THE CASE IT WAS DISCOVERED THAT THE LEAD HAD COME NEARLY ALL THE WAY OUT OF THE PATIENT'S BRAIN AND NEEDED TO RE DO THE RIGHT HEMISPHERE AGAIN. THE LEAD WAS REPLACED WITH A NEW ONE. ISSUE IS RESOLVED AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041290 ↗
• MalfunctionJun 21, 2021Low impedance; Malposition of Device; Difficult to Open or Close; Human-Device Interface Problem; Low impedance; Malposition of Device; Difficult to Open or Close; Human-Device Interface Problem

  IT WAS REPORTED THAT THE PHYSICIAN DID A BILATERAL SUBTHALAMIC NUCLEUS (STN) LEAD PLACEMENT AND EXPRESSED THAT HE HAD DIFFICULTY MAKING THE CLIP SNAP INTO THE STIMLOC BASE. THEY DID NOT VISIBLY SEE ANY EXCESS NYLON MOLDING. THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NEW STIMLOCS WERE OFFERED BUT THE PHYSICIAN DECLINED AND STATED THAT HE WAS ABLE TO FORCE THE CAPS INTO THE STIMLOC BASE. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED DURING A STAGE 2 CASE THE LEAD WAS CHECKED USING THE TWISTLOCK CABLE AND IT WAS FOUND THERE WERE LOW IMPEDANCES ON CONTACT PAIRINGS 3/0 AND 2/1 (RANGING FROM 91-104). THE SURGEON REMOVED THE LEAD FROM THE TWISTLOCK CABLE, INSPECTED IT, AND WIPED IT DOWN WITH A WET THEN DRY SPONGE. THE SURGEON TESTED AGAIN WITH THE SAME RESULTS. IMPEDANCES WERE TESTED ON 0.7, 1.5, AND 3.0 V WITH THE SAME RESULTS WITH THE LEAD APPEARING TO BE INTACT. THE SURGEON THE CONNECTED THE EXTENSION WIRE AND NEUROSTIMULATOR,AND THE SAME RESULTS APPEARED DURING THE IMPEDANCE CHECK. THE SURGEON DECIDED TO THE LEAVE THE LEAD AS IS AND CONSIDERED REPLACING IT IN THE FUTURE. IT WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033432 ↗
• InjuryMay 20, 2021High impedance; High impedance

  IT WAS REPORTED THAT DURING A LEAD PLACEMENT SURGERY, THE IMPEDANCE ON CONTACT 3 WAS HIGH (4257). THE LEAD WAS REMOVED AND REPLACED BEFORE CLOSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855091 ↗
• MalfunctionMay 11, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT HEALTHCARE PROVIDER TESTED IMPEDANCES, LOW IMPEDANCES WERE DISCOVERED, AND PROVIDER SWITCHED OUT FOR A DIFFERENT LEAD AND IMPEDANCES WERE ALL WITHIN NORMAL RANGE. CAUSE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808765 ↗
• InjuryApr 15, 2021Malposition of Device; Malposition of Device

  ON B)(6) 2021 MPXR 828130 (REP): IT WAS REPORTED THAT THE RIGHT BRAIN LEAD WAS REMOVED DUE TO PATIENT EXPERIENCING UNCOMFORTABLE PARESTHESIA AT HIS PROGRAMMED THERAPEUTIC AMPLITUDE. EXPLANTED LEAD WAS FUNCTIONING WELL AND IMPEDANCES WERE NORMAL BUT NOT OPTIMALLY PLACED. PATIENT 'S NEW ELECTRODE WILL BE PROGRAMMED IN 3-4 WEEKS .

  Patient problems: Discomfort; Paresthesia

  MAUDE report 11670701 ↗
• InjuryApr 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SYSTEM WAS REMOVED BECAUSE IT WAS NOT FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627349 ↗
• MalfunctionApr 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LEAD TIP WAS BENT SO THE PHYSICIAN DID NOT USE THE LEAD. A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615970 ↗
• MalfunctionApr 5, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE STIMLOC CLIP WOULD NOT STAY IN PLACE ONCE CLOSED ON THE LEAD. SURGEON TRIED LOOSENING THE BASE RING THINKING IT WAS BENT BUT THAT DID NOT HELP. A NEW STIMLOC KIT WAS OPENED AND A DIFFERENT KIT WAS USEDTHAT EVENTUALLY WORKED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613086 ↗
• MalfunctionMar 29, 2021Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE OCCURRED NEW OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586878 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO EMERGENCY DEPARTMENT POST-OPERATIVELY WITH A HEMORRHAGE, AND COMPLAINTS OF FACIAL PULLING. A CT SCAN WAS TAKEN AND IT SHOWED THE BLOOD WAS REABSORBED. THEY WERE CLEARED TO GO HOME. UNKNOWN IF ANY FACTORS LED TO THE ISSUE. THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE HEMORRHAGE WAS LOCATED ON THE LEFT SIDE AND WAS A INTERVENTRICULAR CEREBRAL HEMORRHAGE. THIS WAS CONFIRMED WITH THE PHYSICIAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Intracranial Hemorrhage

  MAUDE report 11547651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.