DBS ™ 3389S-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169313538), received between Mar 2, 2016 and May 23, 2022 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS A SUSPECTED ISSUE WITH THE LEAD/GUIDEWIRE AND IT APPEARED TO BE BENT. THE LEAD WAS DISCARDED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14475520 ↗
• MalfunctionMar 24, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT WHEN CHECKING IMPEDANCES, THE MANUFACTURER'S REPRESENTATIVE (REP) NOTICED THAT A SHORT CIRCUIT BETWEEN ELECTRODES 10 AND 11 ON THE PATIENT¿S LEFT LEAD. THE REP AND HCP USED TWO TESTING CABLES TO RULE OUT ANY ISSUE WITH THE REPLACEMENT IPG. PATIENT WILL FOLLOW UP WITH NEUROLOGIST TO SEE IF REPROGRAMMING IS NEEDED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE IPG REPLACEMENT WAS DUE T O ERI. THE CAUSE OF THE SHORT CIRCUIT WAS NOT DETERMINED. THE IMPEDANCE VALUES WERE LISTED AS 'LOW' IN THE PROGRAM REPORT. IT WAS UNKNOWN IF THE PATIENT'S DEVICE NEEDED TO BE REPROGRAMMED. THE INFORMATION WAS CONFIRMED WITH THE HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892698 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Complaint, Ill-Defined; Muscle Weakness/Atrophy

  MAUDE report 7655662 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Complaint, Ill-Defined; Muscle Weakness/Atrophy

  MAUDE report 7655614 ↗
• MalfunctionApr 11, 2018Peeled/Delaminated; Peeled/Delaminated

  FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HCP VIA THE REP REPORTING THAT THE CAUSE OF THE SEPARATION WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7423536 ↗
• MalfunctionJan 8, 2018Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PLASTIC LEAD TIP WAS ASKEW WHEN THE HCP TOOK IT OUT SO THEY USED A NEW LEAD TO COMPLETE THE OPERATION TO AVOID ANY ADVERSE EFFECT. THE EVENT WAS CONSIDERED RESOLVED FOLLOWING THE REPLACEMENT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7171227 ↗
• MalfunctionSep 8, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS BENT AT THE PROXIMAL END WHEN COMING OUT OF THE PACKAGING IN THE STERILE FIELD. IT WAS NOT IMPLANTED. ANOTHER LEAD WAS USED AND THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851717 ↗
• MalfunctionAug 18, 2017Device Damaged Prior to Receipt by User; Component Missing; Material Deformation; Device Damaged Prior to Receipt by User; Component Missing; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD MALFUNCTION. THE REP REPORTED THAT THE LEAD WAS BENT UPON OPENING THE BOX. THE REP REPORTED THAT A NEW LEAD WAS OPENED AND USED INSTEAD. NO PATIENT INVOLVEMENT REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803248 ↗
• MalfunctionJun 19, 2017Break; Device Damaged Prior to Receipt by User; Material Deformation; Break; Device Damaged Prior to Receipt by User; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT UPON OPENING THE LEAD PACKAGE TO GO ON TO THE STERILE FIELD, THE LEAD WAS BENT ON THE PROXIMAL END. IT APPEARED THAT NOTHING WAS WRONG WITH THE LEAD ITSELF, THE STYLES IN THE LEAD WERE BENT. THE LEAD WAS NEVER IMPLANTED AND THE SURGEON ASKED FOR A NEW LEAD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6649809 ↗
• MalfunctionJun 6, 2017High impedance; High impedance

  A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED INTROPERATIVE TEST ELECTRODE GROUP OF ¿ANTI-HIGH,¿ REPEATED CONNECTION UNRESOLVED. FACTORS NOTED TO HAVE LED TO THE EVENT WERE NOTED AS ¿CAUSES OF IMPLANTED PRODUCT/PATIENT EDEMA DURING SURGERY.¿ TROUBLESHOOTING WAS NOTED AS INTRAOPERATIVE MULTIPLE TESTS, IMPEDANCE WAS STILL HIGH ON ALL ELECTRODE COMBINATIONS (>4000 OHMS), EXCLUDING THE REASONS FOR CONNECTION. SUSPECTED IMPEDANCE ITSELF HIGH, REPLACE THE ELECTRODE, TEST AGAIN. IT WAS NOTED THAT DURING THE SURGERY, REPLACED WITH A NEW ELECTRODE, AND THE IMPEDANCE TEST WAS NORMAL. THE PROBLEM HAD RESOLVED. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6617042 ↗
• MalfunctionMay 23, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REPORTING AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE ELECTRODE HEAD WAS BENT. THE LEAD WAS NOT IMPLANTED. IT WAS UNKNOWN IF THERE WERE ANY FACTORS THAT CONTRIBUTED TO THE EVENT. NO DIAGNOSTICS WERE PERFORMED. A NEW LEAD WAS IMPLANTED. THE PROBLEM WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6586756 ↗
• MalfunctionMay 3, 2017Migration or Expulsion of Device; Unstable; Migration or Expulsion of Device; Unstable

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT AFTER THE COVER OF THE STIMLOC WAS PLACED DURING THE IMPLANT SURGERY, THE LEAD SUNK 1-2 MM DEEPER THAN IT'S INTENDED LOCATION; THE HCP THOUGHT IT WAS AN ELECTRODE DESIGN PROBLEM. THE HEALTH CARE PROVIDER (HCP) WAS ABLE TO PULL THE LEAD OUT 2 MM AFTER THE ISSUE WAS DISCOVERED. THE PATIENT WAS PLACED IN TREATMENT AND THEIR STATUS WAS NORMAL. THE STIMULATION WAS NOT POWERED ON SO THERE WAS NO EFFECT OBSERVED, YET. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. PLEASE SEE REPORT NUMBER 2649622-2017-04896.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540681 ↗
• MalfunctionMay 3, 2017Migration or Expulsion of Device; Unstable; Migration or Expulsion of Device; Unstable

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT AFTER THE COVER OF THE STIMLOC WAS PLACED DURING THE IMPLANT SURGERY, THE LEAD SUNK 1-2 MM DEEPER THAN IT'S INTENDED LOCATION; THE HCP THOUGHT IT WAS AN ELECTRODE DESIGN PROBLEM. THE HEALTH CARE PROVIDER (HCP) WAS ABLE TO PULL THE LEAD OUT 2 MM AFTER THE ISSUE WAS DISCOVERED. THE PATIENT WAS PLACED IN TREATMENT AND THEIR STATUS WAS NORMAL. THE STIMULATION WAS NOT POWERED ON SO THERE WAS NO EFFECT OBSERVED, YET. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540672 ↗
• MalfunctionApr 28, 2017Low impedance; Low impedance

  A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED DURING THE SURGERY, IT WAS FOUND THE RESISTANCE WAS LOW, 29, AND THE HCP HAD TO REPLACE A NEW ONE TO COMPLETE THE SURGERY SUCCESSFULLY. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529354 ↗
• MalfunctionApr 28, 2017Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THE PACKAGE WAS OPENED AND FOUND THAT THE ELECTRODE WAS BENT, AND COULD NOT BE IMPLANTED IN A CONSUMER. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529297 ↗
• MalfunctionApr 14, 2017Low impedance; Low impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) LEAD IMPLANTATION SURGERY ON (B)(6) 2017, THE RESISTANCE/IMPEDANCE VALUES WERE FOUND TO BE TOO LOW; 0<(>&<)>1= 12OHMS, 0<(>&<)>2= 12OHMS, 0<(>&<)>3= 24OHMS, 1 <(>&<)>2= 11OHMS, 1<(>&<)>3= 23OHMS, 2<(>&<)>3= 23OHMS. A NEW LEAD WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THE PATIENT'S STATUS IS CURRENTLY WELL. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6493807 ↗
• MalfunctionApr 10, 2017Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE CAUSE OF THE LEAD BEING BENT WAS NOT DETERMINED. IT WAS UNKNOWN IF THE LEAD WOULD FOUND TO BE BENT WHEN TAKEN OUT OF THE PACKAGE OR AFTER THE LEAD BEEN HANDLED PRIOR TO IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477154 ↗
• MalfunctionApr 3, 2017High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATED THE IMPEDANCE WAS NORMAL WITH THE NEW LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455307 ↗
• MalfunctionMar 23, 2017Break; Break

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE FAR-END SIZE OF THE LEADS WERE ONLY 1.0 MM BUT THE STANDARD WAS 1.5 MM IN THE PRODUCT DESCRIPTION. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THE LEAD WAS USED IN THE SURGERY, THERE WAS NO ISSUE ABOUT SAFETY, NO ACTIONS OR INTERVENTIONS WERE TAKEN, AND THIS WAS THE ONLY CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6429549 ↗
• MalfunctionMar 21, 2017Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE NEW LEAD WAS IMPLANTED AND OLD PRODUCT EXPLANTED ON (B)(6) 2017. ONLY THE OPEN LEAD WASN'T IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 6421496 ↗
• MalfunctionMar 17, 2017Component Missing; Component Missing

  ADDITIONAL INFORMATION RECEIVED REPORTED WHEN THE DOCTOR OPENED THE ELECTRODE PACKAGE DURING SURGERY, HE FOUND THAT THE ELECTRODE LOCKING DEVICE CONTAINED TWO CLIPS, BUT DID NOT HAVE THE CAP USED FOR SKULL REPAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6414108 ↗
• InjuryMar 2, 2016High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PREOPERATIVE A PACKAGE ABNORMALITY WAS FOUND BEFORE OPENED, THE DEVICE WAS INSPECTED PRIOR TO USE, AND AN ABNORMALITY WAS FOUND. THE ABNORMALITY WAS DESCRIBED AS ¿UNABLE TO CONTINUE THIS OPERATION AS HIGH ELECTRODE RESISTANCE WAS DETECTED IN THE TEST.¿ NO LEAD FRACTURES WERE NOTED. A DIFFERENT ELECTRODE WAS USED TO IMPLANT AND THE RESULT WAS NORMAL. THE PATIENT¿S CURRENT STATUS WAS NOTED AS NORMAL AND THERE WAS NO PATIENT IMPACT. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN CLARIFICATION AROUND THE ABNORMALITY REPORTED. IF RECEIVED, THIS EVENT WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5475666 ↗

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.