DBS ™ 3387S-40 (UDI 00643169313491)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169313491), received between May 4, 2017 and Jan 15, 2020 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2020Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE LOCATION WAS WHAT THE ORIGINAL SURGICAL PLAN WAS WHEN THE LEAD WAS FIRST IMPLANTED. AFTER SURGERY WAS COMPLETE IT WAS DISCOVERED THAT THE PATIENT DIDN¿T HAVE EFFICACY ON THAT SIDE. A REVISION WAS DONE TO IT WAS DISCOVERED INTRA-OP THE FINAL LOCATION OF THE LEAD WAS 7.5MM ABOVE ORIGINAL LEAD LOCATION.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9591590 ↗
• MalfunctionFeb 28, 2019Device Damaged Prior to Receipt by User; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) IT WAS REPORTED THAT THE FIRST THREE LEADS WERE FINE, IT WAS THE FOURTH THAT WAS THE ISSUE. REP STATED THAT THEY IMPLANTED THE LEAD, TESTED IT, AND 3 AND 1 CONTACT WOULD NOT READ, SAYING THERE WAS A FAULT BETWEEN 3 AND 1. TOOK TWIST LOCK OFF AND PUT ANOTHER TWIST LOCK ON. TESTED THE LEAD AND THE ISSUE WAS STILL PRESENT. USED ALLIGATOR CLIPS TO TEST THE LEAD, ISSUE STILL PRESENT. EXPLANTED LEAD AND PUT IN A NEW ONE. TESTED WITH 2ND TWIST LOCK. 3 AND 0 DID NOT WORK SHIFTED TWIST LOCK CABLE(TOOK IT OFF, UNPLUGGED FROM EXTERNAL NEUROSTIMULATOR STIMULATOR -ENS, PLUGGED IT BACK INTO TO ENS, AND THE FAULT RESOLVED ITSELF.) REP STATED THESE ARE BOTH OUT OF BOX FAILURES. THE REP NOTED THIS IS THE SECOND TIME THIS HAS HAPPENED AND CONFIRMED IT WAS DOCUMENTED BY A DIFFERENT A REP. NO SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377815 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED BY THE REP VIA THE DOCTOR THAT THE PATIENT¿S SEIZURES WERE NOT FROM A PRE-EXISTING CONDITION. THE EXACT RELATIONSHIP BETWEEN THE DEVICES AND THE SEIZURES IS UNKNOWN, BUT THE PATIENT STARTED HAVING SEIZURES, AS REPORTED BY THEIR FAMILY, SOMETIME IN THE WEEK AFTER THE LEADS WERE PLACED IN THE BRAIN. THE STIMULATION WAS NOT ON AS THE PATIENT DIDN'T HAVE THE IPG PLACED DUE TO THEIR SEIZURES. IT WAS AGAIN STATED THAT THE SEIZURES DEVELOPED AFTER THE BRAIN ELECTRODES WERE PLACED, ALTHOUGH THE SEIZURES WERE NOT DURING THE SURGERY. A CT OF THE BRAIN HAD SHOWN THAT THE AREA OF THE ABNORMALITY NOT BELIEVED TO BE INFECTION. THE PATIENT WAS HOSPITALIZED AND PLACED ON ANTI SEIZURE MEDICATIONS. THEY WERE STILL TAKING ANTI SEIZURE MEDICATIONS AND WERE NO LONGER INPATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Seizures

  MAUDE report 8125009 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED BY THE REP VIA THE DOCTOR THAT THE PATIENT¿S SEIZURES WERE NOT FROM A PRE-EXISTING CONDITION. THE EXACT RELATIONSHIP BETWEEN THE DEVICES AND THE SEIZURES IS UNKNOWN, BUT THE PATIENT STARTED HAVING SEIZURES, AS REPORTED BY THEIR FAMILY, SOMETIME IN THE WEEK AFTER THE LEADS WERE PLACED IN THE BRAIN. THE STIMULATION WAS NOT ON AS THE PATIENT DIDN'T HAVE THE IPG PLACED DUE TO THEIR SEIZURES. IT WAS AGAIN STATED THAT THE SEIZURES DEVELOPED AFTER THE BRAIN ELECTRODES WERE PLACED, ALTHOUGH THE SEIZURES WERE NOT DURING THE SURGERY. A CT OF THE BRAIN HAD SHOWN THAT THE AREA OF THE ABNORMALITY NOT BELIEVED TO BE INFECTION. THE PATIENT WAS HOSPITALIZED AND PLACED ON ANTI SEIZURE MEDICATIONS. THEY WERE STILL TAKING ANTI SEIZURE MEDICATIONS AND WERE NO LONGER INPATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Seizures

  MAUDE report 8124992 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN MRI FOR "NEWONSET SEIZURES AFTER DBS PLACEMENT". CALLER SAID HER NOTES INDICATE THERE IS A CONCERN FOR UNDERLYING SEIZURE DISORDER AFTER THE PATIENT HAD HIS DBS LEADS PLACED. IT IS UNKNOWN IF THE SYMPTOMS ARE RELATED TO THE DEVICE OR THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Seizures

  MAUDE report 7998186 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN MRI FOR "NEWONSET SEIZURES AFTER DBS PLACEMENT". CALLER SAID HER NOTES INDICATE THERE IS A CONCERN FOR UNDERLYING SEIZURE DISORDER AFTER THE PATIENT HAD HIS DBS LEADS PLACED. IT IS UNKNOWN IF THE SYMPTOMS ARE RELATED TO THE DEVICE OR THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Seizures

  MAUDE report 7998182 ↗
• InjuryAug 18, 2017Malposition of Device; Malposition of Device

  A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT A LEAD WAS IMPLANTED ON (B)(6) DURING A SECOND IMPLANT PROCEDURE, IT WAS DETERMINED THAT THE LEAD WAS TOO HIGH. A LEAD REVISION WAS PERFORMED TO RESOLVE THE ISSUE. NO MEDICAL SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS ARE ANTICIPATED. THE PATIENT WAS IMPLANTED FOR MOVEMENT DISORDERS

  Patient problems: Complaint, Ill-Defined; No Known Impact Or Consequence To Patient

  MAUDE report 6805388 ↗
• MalfunctionMay 4, 2017Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEAD IMPLANTED, BUT THE FIRST LEAD WAS BENT OUT OF BOX. THE PHYSICIAN WAS TRYING TO MEASURE THE LEAD, BUT IT WOULD NOT LIE FLAT IN THE MEASUREMENT TOOL, SO A NEW LEAD WAS OPENED. THE SECOND LEAD WAS IMPLANTED AND IMPEDANCES WERE TESTED WITH A SCREENING CABLE. LOW IMPEDANCES WERE FOUND ON CONTACTS 2 <(>&<)> 3. THE PHYSICIAN RECONNECTED BARREL CONNECTOR ON THE LEAD AND MEASURED LOW IMPEDANCES ON ALL COMBINATIONS TESTED AT 3.0 VOLTS. THE SECOND LEAD WAS EXPLANTED AND REPLACED WITH A THIRD LEAD WHICH HAD NORMAL IMPEDANCES. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6543938 ↗

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-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.