DBS™ 3389S-40 (UDI 00643169752276)Recalls & reported problems
Medtronic, Inc. · LEAD 3389S-40 EMAN SCNR CBL RMV MR CDTNL · Class 3 · Implant
Quick summary
This Medtronic deep brain stimulation lead is an implanted wire used to treat Parkinsonian tremor. Its 183 reports include 1 death and 40 injuries. Many describe leads that break or show high electrical resistance, and some report leads arriving damaged or being replaced during surgery. Some reports mention brain bleeding and stroke, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 183
- Deaths reported
- 1
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 00643169752276), received between Jan 2, 2018 and Apr 15, 2026 — classified as 1 death, 40 injuries, 142 malfunctions.
The most frequently reported specific device problem is “Break” (35 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.
Reports received per month
Most reported problems
Device problems
- Break35
- High impedance35
- Adverse Event Without Identified Device or Use Problem32
- Device Damaged Prior to Receipt by User29
- Insufficient Device Problem Information23
- Material Deformation22
- Material Twisted/Bent20
- Unstable14
Patient problems
- No Known Impact Or Consequence To Patient90
- No Clinical Signs, Symptoms or Conditions70
- Intracranial Hemorrhage10
- Stroke/CVA6
- Unspecified Infection5
- Blurred Vision3
- Fluid Discharge3
- Dysphasia2
Recent adverse event reports
The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS POSTOPERATIVE BLEEDING AND PURULENT DISCHARGE WERE OBSERVED AT THE CRANIAL LEAD SITE. IT WAS RECOMMENDED TO COMMUNICATE WITH THE PHYSICIAN. THE ISSUE WAS SAID TO BE RESOLVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Purulent Discharge
MAUDE report 24886604 ↗MalfunctionNov 28, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD ELECTRIC RESISTANCE WAS TOO HIGH. THE SURGERY WAS RESOLVED BY REPLACING WITH A NEW LEAD. NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15870241 ↗MalfunctionJul 27, 2022High impedance; High impedance
IT WAS REPORTED THAT THE RESISTANCE OF THE LEAD WAS FOUND TO BE TOO HIGH. THE LEAD WAS REPLACED AND THE OPERATION WAS COMPLETED. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15114639 ↗MalfunctionJun 24, 2022Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE STIMLOC SCREW OF THE LEAD WAS FOUND TO BE BROKEN. REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY ON THE SAME DAY. THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14801965 ↗MalfunctionMay 12, 2022High impedance; Unstable; Difficult to Open or Close; Unintended Movement; High impedance; Unstable; Difficult to Open or Close; Unintended Movement
IT WAS REPORTED THAT THE STIMLOC LEAD CLIP OF THE LEAD COULD NOT BE FIXED, AND THE LEAD IMPEDANCE WAS HIGH. THEY REPLACED THE LEAD AND THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14375891 ↗MalfunctionApr 19, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT AFTER UNPACKING DURING THE SURGERY, IT WAS FOUND THAT THE STIMLOC LOCK COULD NOT BE LOCKED. THE SURGERY WAS COMPLETED BY REPLACING IT WITH THE NEW STIMLOC ACCESSORIES ON THE SAME DAY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION CURRENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142439 ↗MalfunctionApr 15, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT AFTER UNPACKING DURING THE OPERATION, IT WAS FOUND THAT THE LEAD WAS BENT. THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. AT PRESENT, THE PATIENT IS HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14118108 ↗MalfunctionApr 6, 2022Unstable; Material Deformation; Unstable; Material Deformation
IT WAS REPORTED THAT THE LEAD WAS FOUND TO BE BENT WHEN UNPACKING FOR THE SURGERY. AT THE SAME TIME THE STIMLOC LEAD LOCK COULD NOT BE PRESSED INTO THE BASE AND COULDN'T BE FIXED. A NEW LEAD WAS USED AND THE SURGERY WAS COMPLETED THE SAME DAY. THERE WASN'T ANY INFLUENCE ON THE PATIENT'S CURRENT TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14022396 ↗MalfunctionApr 6, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT AFTER UNPACKING THE LEAD DURING THE SURGERY IT WAS FOUND THAT THE LEAD WAS BENT. THEY REPLACED IT WITH A NEW LEAD AND THE SURGERY WAS COMPLETED THE SAME DAY. THERE WASN'T ANY INFLUENCE ON THE PATIENT'S NORMAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14021956 ↗MalfunctionApr 6, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE LEAD WAS FOUND BENT DURING THE SURGERY AND WAS REPLACED WITH A NEW LEAD ON THE SAME DAY TO COMPLETE THE SURGERY. THERE WASN'T ANY INFLUENCE ON THE NORMAL TREATMENT CURRENTLY. THE PATIENT WAS CURRENTLY HOSPITALIZED AND UNDER OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14021846 ↗MalfunctionApr 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE SURGERY, THE LEAD WAS FOUND TO BE BENT. THE LEAD WAS REPLACED WITH A NEW LEAD TO COMPLETE THE SURGERY ON THE SAME DAY. THERE ISN'T ANY INFLUENCE ON THE NORMAL TREATMENT CURRENTLY. THE PATIENT WAS CURRENTLY UNDER OBSERVATION IN HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13995428 ↗MalfunctionMar 31, 2022Unstable; Unstable
IT WAS REPORTED THAT THE STIMLOC BURR HOLE CLIP COULD NOT FIX THE LEAD DURING THE OPERATION. THE STIMLOC CLIP WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THERE ISN'T ANY INFLUENCE ON THE NORMAL TREATMENT CURRENTLY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13970562 ↗MalfunctionMar 30, 2022Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED THAT TWO STIMLOCS WERE FOUND TO BE FAULTY DURING THE SURGERY. ONE SET OF STIMLOC FIXING SCREW CAP WAS BROKEN, AND THE OTHER SET OF STIMLOC LEAD CLIP COULD NOT BE CLAMPED. THEY WERE REPLACED WITH TWO NEW STIMLOCS ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION CURRENTLY. REFER TO MANUFACTURER REPORT #2182207-2022-00542 FOR RELATED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13951235 ↗MalfunctionMar 30, 2022Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED THAT TWO STIMLOCS WERE FOUND TO BE FAULTY DURING THE SURGERY. ONE SET OF STIMLOC FIXING SCREW CAP WAS BROKEN, AND THE OTHER SET OF STIMLOC LEAD CLIP COULD NOT BE CLAMPED. THEY WERE REPLACED WITH TWO NEW STIMLOCS ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION CURRENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13951215 ↗MalfunctionMar 24, 2022Break; Positioning Problem; Unintended Movement; Insufficient Device Problem Information; Break; Positioning Problem; Unintended Movement; Insufficient Device Problem Information
IT WAS REPORTED THAT THE LEAD LOCK BASE (STIMLOC) SCREW WAS SLIPPED AND BROKEN. THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT WAS CURRENTLY HOSPITALIZED FOR OBSERVATION. IT IS UNKNOWN IF THERE WERE ANY CONTRIBUTING FACTORS THAT MAY HAVE CAUSED OR LED TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13897148 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT IT WAS FOUND DURING THE OPERATION THAT THE LEAD LOCK WAS BROKEN. THE OPERATION WAS COMPLETED BY REPLACING WITH THE NEW LEAD ON THE SAME DAY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) CLARIFYING THAT THE LEAD LOCK IS REFERRING TO THE STIMLOC CLIP. THE ISSUE WAS FOUND WHEN USED AFTER OPENING THE PACKAGE. THE CAUSE OF THE BROKEN STIMLOC CLIP IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13805990 ↗MalfunctionMar 11, 2022Low impedance; Low impedance
IT WAS REPORTED THAT THE RESISTANCE OF THE LEAD WAS FOUND TO BE TOO LOW, AND REPLACED WITH A NEW LEAD ON THE SAME DAY OF SURGERY. NO SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731928 ↗MalfunctionFeb 25, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
IT WAS REPORTED THAT IT WAS FOUND THE LEAD WAS DEFORMED DURING THE SURGERY. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW LEAD. AT PRESENT, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13601419 ↗MalfunctionFeb 25, 2022Low impedance; Low impedance
IT WAS REPORTED THAT THE LEAD RESISTANCE WAS FOUND TO BE TOO LOW DURING THE OPERATION ON (B)(6) 2022, AND THE NEW LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE OPERATION. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13601045 ↗MalfunctionJan 14, 2022Break; Break
IT WAS REPORTED THAT THE SURGEON REMOVED STYLET INCORRECTLY WHICH BROKE THE PROXIMAL END OF LEAD. THE BROKEN LEAD WAS REPLACED WITH A DIFFERENT LEAD. THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13261503 ↗MalfunctionJan 11, 2022Unstable; Unstable
IT WAS REPORTED THAT THE LEAD CLIP OF THE LEAD WAS FOUND TO BE UNABLE TO BE FIXED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A NEW LEAD ON THE SAME DAY AND THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13227842 ↗MalfunctionJan 5, 2022High impedance; High impedance
IT WAS REPORTED THAT DURING THE OPERATION, THE LEAD IMPEDANCE WAS FOUND TO BE TOO HIGH. THEY REPLACED THE LEAD WITH A NEW LEAD ON THE SAME DAY AND COMPLETED THE OPERATION. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13163049 ↗MalfunctionJan 5, 2022High impedance; High impedance
IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS DISCOVERED DURING THE OPERATION THAT THE LEAD IMPEDANCE WAS ABNORMAL. THE OPERATION WAS COMPLETED BY REPLACING THE LEAD WITH A NEW LEAD ON THE SAME DAY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13162813 ↗MalfunctionJan 5, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE LEAD TIP WAS FOUND TO BE BENT DURING THE OPERATION ON (B)(6) 2021. THE OPERATION WAS COMPLETED WITH A NEW LEAD 3389S-40 ON THE SAME DAY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13162809 ↗MalfunctionJan 5, 2022High impedance; High impedance
IT WAS REPORTED THAT THE LEAD RESISTANCE WAS FOUND TO BE TOO HIGH DURING THE OPERATION AND THE OPERATION WAS COMPLETED BY REPLACING THE NEW LEAD ON THE SAME DAY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13162392 ↗
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-2241-2026 · May 13, 2026 · Open, ClassifiedMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- Z-2240-2026 · May 13, 2026 · Open, ClassifiedMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Z-0206-2025 · Sep 24, 2024 · Open, ClassifiedMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
- Z-0372-2025 · Sep 18, 2024 · Open, ClassifiedMedtronic 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 · CompletedLEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Z-1128-2022 · Mar 30, 2022 · Open, ClassifiedPercept BrainSense Implantable Neurostimulator (INS), Model B35200
- Z-0418-2022 · Oct 19, 2021 · Open, ClassifiedModel B35200 - Percept PC BrainSense Implantable Neurostimulator
- Z-0201-2022 · Sep 23, 2021 · Open, ClassifiedClinician Programmer Application (CPA) model A610 Clinician Software Application
- Z-1368-2021 · Mar 9, 2021 · Open, ClassifiedA610 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 · TerminatedDBS 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 · TerminatedDBS 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 · TerminatedMedtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
- Z-1617-2015 · Apr 16, 2015 · TerminatedMedtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Z-0279-2014 · Sep 30, 2013 · TerminatedMedtronic 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 · TerminatedMedtronic 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.
Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR devices
- Activa® RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 deaths1,849 reports
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Infinity™ 6662St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- Activa® SC 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death443 reports
- Infinity™ 7St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor2 deaths371 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.