DBS™ 3389S-40 (UDI 00613994981363)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994981363), received between Dec 2, 2016 and Feb 12, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Therapy Delivered to Incorrect Body Area” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2019Low impedance; Low impedance

  ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY UPDATED THEIR INITIAL REPORT CONFIRMING THE INS WAS REPLACED ON 08 FEBRUARY 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331001 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT DEVELOPED A SMALL PIMPLE-LIKE AREA OVER THE CONNECTOR BOOT THAT GRADUALLY INCREASED IN SIZE AND DRAINAGE. THE PATIENT HAD REPORTED IT AS A BLISTER. THE CONNECTOR BOOTS WERE REPLACED AND THE LESION WAS EXCISED. SURGICAL OBSERVATION INDICATED HYPERREACTIVE SCAR TISSUE AS WELL. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. THE ETIOLOGY WAS STATED TO BE POSSIBLY RELATED TO THE DEVICE/THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Scar Tissue; Skin Inflammation

  MAUDE report 8057479 ↗
• InjuryApr 11, 2017Break; Intermittent Continuity; High impedance; Therapy Delivered to Incorrect Body Area; Break; Intermittent Continuity; High impedance; Therapy Delivered to Incorrect Body Area

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY. IT WAS REPORTED THAT THE EVENT BEGAN OCCURRING ON (B)(6) 2017. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Complaint, Ill-Defined; Dysphasia; Shaking/Tremors; Therapeutic Effects, Unexpected; Undesired Nerve Stimulation

  MAUDE report 6482439 ↗
• InjuryFeb 1, 2017Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY. IT WAS REPORTED THAT THE ETIOLOGY WAS UPDATED TO NOT RELATED TO THE DEVICE/THERAPY, BUT RELATED TO THE IMPLANT PROCEDURE; SURGERY/ANESTHESIA WAS NOTED.

  Patient problems: Infarction, Cerebral; Stroke/CVA; Therapeutic Effects, Unexpected; Tingling; Undesired Nerve Stimulation

  MAUDE report 6293361 ↗
• MalfunctionDec 2, 2016Material Deformation; Material Deformation

  A HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE LEAD, OR MORE LIKELY THE STYLET, WAS BENT OUT OF BOX AND THEREFORE WAS NOT USED FOR IMPLANTATION. THE CAUSE OF THE BEND IN THE LEAD IS UNKNOWN. THE SURGERY WAS CONTINUED WITH OTHER LEADS AND TOOK PLACE ON (B)(6) 2016. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6141068 ↗

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.