DBS 3389S-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00643169516571), received between Nov 29, 2016 and Jun 5, 2026 — classified as 14 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR NORMAL END OF SERVICE BATTERY REPLACEMENT TODAY. IN PRE-OP, ALL IMPEDANCES WERE NORMAL, HOWEVER, DURING THE PROCEDURE THERE WAS A SHORT (200 OHMS) DISCOVERED BETWEEN CONTACTS 8 AND 9 ON THE RIGHT HEMISPHERE. CALLER STATED THE PATIENT WAS PROGRAMMED WITH A DOUBLE MONOPOLE (C+ 8- 9-) ON THOSE CONTACTS. DURING THE PROCEDURE, THE EXTENSION TAILS WERE SWITCHED IN THE PORTS OF THE BATTERY AND IT WAS DETERMINED THAT THE ISSUE WAS RELATED TO THE LEAD OR EXTENSION AS OPPOSED TO THE BATTERY. THE PATIENT WASN'T CONSENTED FOR ANYTHING OTHER THAN THE BATTERY REPLACEMENT SO ONLY THE BATTERY WAS REPLACED TODAY . IN POST-OP ,THE IMPEDANCE MEASUREMENT BETWEEN 8-9 HAD DECREASED TO 44 OHMS. CALLER STATED PROGRAMMING WAS LEFT AS IS ON C+ 8- 9- AND PATIENT APPEARED TO BE GETTING SYMPTOM CONTROL FOR TREMOR WITH IT NOTED THAT PATIENT WAS STILL COMING OFF SEDATION AT THE TIME. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER STATED RUSH UNIVERSITY WILL BE RETURNING THE EXPLANTED BATTERY. CALLER STATED THEY PLAN TO CHECK-IN WITH THE PATIENT IN A WEEK TO SEE HOW THEIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409969 ↗
• MalfunctionMar 26, 2026Insufficient Device Problem Information

  THE HEALTHCARE PROVIDER PROVIDED ADDITIONAL INFORMATION CLARIFYING THAT THE LEADS ARE NOT BROKEN AND ADDED THAT THEY SEE THE PATIENT REGULARLY AND DBS ANALYST EVERY 3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699774 ↗
• InjuryJan 27, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING A DIFFERENT DATE WAS SELECTED FOR SURGERY, HOWEVER, THE EXACT DATE WAS NOT KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236881 ↗
• MalfunctionJan 13, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED JUST VERY RECENTLY, A CUSTOMER ASKED FOR CLARIFICATION ON A DISCREPANCY THEY OBSERVED BETWEEN THE ORIGINAL LABEL AND THE NATIONALIZATION LABEL FOR THE CODE 3389-S, WHERE THE COUNTING OF ORIGINAL LABEL IS 3 YEARS, BUT THE FORMER NATIONALIZATION LABEL SAYS 4 YEARS. A SHELF LIFE MEMO CLARIFIED THE DIFFERENCE ON SHELF LIFE, 3 YEARS FOR 3389-S BUT 4 YEARS ONLY FOR 3389. THERE WERE TWO DIFFERENT DATA FOR EXPIRATION DATE FOR THE 3389-S. 3 YEARS FROM THE COUNTING OF ORIGINAL AND 4 YEARS FOR LOCAL. NO EXPIRED PRODUCT WAS USED OR IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167564 ↗
• InjuryOct 25, 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 THE PATIENT HAD AN INFECTION COMPLICATION THAT RESULTED IN PROLONGED HOSPITALIZATION. THE PATIENT HAD A HEAD CT PERFORMED THAT SHOWED MILD SOFT TISSUE SWELLING AND INDURATION ALONG THEIR LEFT POSTAURICULAR AREA AND TEMPOROPARIETAL SCALP ALONG THE COURSE OF THE PRIOR ELECTRODE ARE INDICATIVE OF SOFT INFECTION/CELLULITIS WITHOUT ABSCESS. THERE WAS NO EVIDENCE OF OSTEOMYELITIS IN THE ADJACENT CALVARIUM. THEY UNDERWENT A SCALP WASHOUT SEVERAL DAYS LATER. THEIR INCISION HAD SINCE HEALED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 8006671 ↗
• MalfunctionSep 28, 2018Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND CONFIRMED WITH THE HCP. THE LOT NUMBER OF THE STIM LOC BURR HOLE COVER WAS PROVIDED. THE PRODUCT WAS TO BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920647 ↗
• InjuryJul 30, 2018Connection Problem; Naturally Worn; Connection Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7731879 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT'S INCISION AT HIS HEAD WAS NOT HEALING PROPERLY. THE SURGEON INSPECTED THE INCISION AND DECIDED TO REMOVE THE STIMLOC AND LEAD ON (B)(6) 2018 TO ALLOW THE SKIN TO PROPERLY HEAL. NO KNOWN EXTERNAL FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO INFECTION WAS REPORTED. IT WAS REPORTED THE SURGEON WOULD RE-IMPLANT THE LEAD ONCE THE INCISION HEALED. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 7590837 ↗
• MalfunctionMay 17, 2018Activation, Positioning or Separation Problem; Device Operates Differently Than Expected; Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS CLARIFIED THAT THE PREVIOUSLY REPORTED EVENT WAS FOUND INTRAOPERATIVELY, NOT OUT OF THE BOX. IT WAS ALSO CLARIFIED THAT THE FRACTURE WAS ON THE FRONT SIDE OF THE FIXED ELECTRODE CAP. THE HCP USED A JOHNSON SCREW TO OPEN THE CHANNEL, AND THEN USED THE ORIGINAL MANUFACTURER SCREW TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522025 ↗
• MalfunctionMar 22, 2018Connection Problem; Device Operates Differently Than Expected; Connection Problem; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THE ISSUED OCCURRED DURING INTRAOPERATIVE TESTING. IT WAS UNKNOWN WHAT SYMPTOMS THE PATIENT EXPERIENCED. IT WAS FURTHER CLARIFIED THAT THE LEAD WAS UNABLE TO LOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361671 ↗
• MalfunctionMar 13, 2018Bent; Break; Bent; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD ELECTRODE WAS FOUND TO HAVE BEEN BENT IN THE OPERATION. THE NEW ELECTRODE WAS REPLACED TO COMPLETE THE OPERATION. THE REASON FOR FAILURE WAS UNKNOWN, HOWEVER THE ISSUE WAS RESOLVED. TROUBLESHOOTING WAS UNKNOWN. 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 7336742 ↗
• MalfunctionMar 9, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED REGARDING A RETURNED PRODUCT FROM AN UNKNOWN SOURCE. IT WAS REPORTED THAT THE LEAD WAS BENT. NO SYMPTOMS REPORTED. NO OUT OF BOX FAILURE WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327442 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE 400 HOTLINE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT IS UNKNOWN WHO INITIALLY REPORTED THE EVENT TO THE 400 HOTLINE; FOLLOW-UP IS BEING CONDUCTED TO OBTAIN CLARIFICATION. IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2018, THE PATIENT BEGAN TO HEMORRHAGE, SO THE LEAD(S) WERE REPLACED. IT IS UNKNOWN IF ONE OR TWO LEADS WERE IMPLANTED AND REPLACED SO FOLLOW-UP IS BEING CONDUCTED TO OBTAIN CLARIFICATION. THE CAUSE AND WHAT TROUBLESHOOTING THAT WAS PERFORMED RELATED TO THE EVENT WAS STATED TO BE UNKNOWN. IT WAS THEN CONFIRMED THAT THE HEMORRHAGE HAD BEEN STOPPED, BUT THE PATIENT REMAINED IN OBSERVATION. THE HOSPITAL WAS IN POSSESSION OF THE DEVICE(S) AND IT WAS UNKNOWN IF IT/THEY WILL BE RETURNED. THE EVENT WAS CONSIDERED RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 7230474 ↗
• MalfunctionJan 4, 2018Bent; Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING AN EVENT WITH NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A LEAD WAS BENT AT THE DISTAL TIP AND THE SURGEON WAS NOT COMFORTABLE IMPLANTING IT. A NEW LEAD WAS OPENED AND THIS RESOLVED THE ISSUE. 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 7165109 ↗
• MalfunctionDec 11, 2017High impedance; High impedance

  FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HCP VIA THE REP REPORTING THAT THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED. THE REP REPORTED THAT THE HIGH IMPEDANCES WERE NOT RESOLVED AS THE HCP CHOSE NOT TO TROUBLESHOOT. THE REP REPORTED THAT THE EXTENSION AND BATTERY PLACEMENT WAS SCHEDULED FOR (B)(6) 2018. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105550 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. THE PATIENT SHOWED SIGNS OF INTRACRANIAL BLEEDING ON THE RIGHT SIDE OF THE BRAIN ON POST-OPERATIVE IMAGING FOLLOWING BILATERAL LEAD IMPLANT. ADDITIONAL FACTORS THAT MAY HAVE LED TO/CONTRIBUTED TO THE EVENT INCLUDE LOW PLATELET COUNT PRIOR TO SURGERY WHICH WAS BEING MONITORED. PLATELETS WERE ADMINISTERED DURING SURGERY. THE PHYSICIAN SUSPECTED THE BLEEDING WAS A RESULT OF THE PLATELET DYSFUNCTION AND NOT SPECIFICALLY RELATED TO THE DEEP BRAIN STIMULATION (DBS) LEADS. A CRANIOTOMY WAS SCHEDULED TO EVACUATE THE HEMATOMA, BUT IT WAS NOT KNOWN IF THE RIGHT LEAD OR BOTH LEADS WOULD BE REMOVED IN THE PROCESS OF THE PROCEDURE. BOTH LEADS REMAINED IMPLANTED AT THE TIME OF THIS REPORT AND THE ISSUE WAS UNRESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 7071833 ↗
• MalfunctionOct 25, 2017Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT DURING IMPLANT SURGERY IT WAS FOUND THAT THE ELECTRODE WAS BENT. AS A RESULT, A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN WHAT TROUBLESHOOTING WAS PERFORMED RELATED TO THE EVENT OR WHAT THE CAUSE OF THE EVENT WAS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976382 ↗
• MalfunctionOct 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE BASE OF THE STIMLOC FAILED TO BE FIXED RESULTING IN A DIFFICULTY ATTACHING THE SUPPORT CLIP BECAUSE THERE WAS SPACE BETWEEN THE BASE AND THE CRANIAL BONE. DUE TO THE PATIENT'S UNDERLYING INFECTIOUS HEPATITIS C VIRUS AND THERE BEING A LOT OF BODY FLUID ON SOME OF THE PRODUCT PARTS, ANOTHER KIT WAS USED. THE BASE SCREW OF THE NEW KIT WAS ADJUSTED AND TIGHTENED PROPERLY AND THE STIMLOC ATTACHED NORMALLY WITH NO ISSUES. THERE WAS NO PATIENT IMPACT OR SYMPTOMS AS A RESULT OF THE EVENT. THERE WERE NO ENVIRONMENTAL FACTORS THAT LED OR CONTRIBUTED TO THE ISSUE, WITH THE PROBLEM RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6974225 ↗
• MalfunctionOct 16, 2017Bent; Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. NO PATIENT INVOLVEMENT. IT WAS REPORTED THE LEAD WAS OPENED AND THE SURGEON NOTICED THAT THE DISTAL TIP OF CONTACT ZERO WAS SLIGHTLY BENT AND THEY DIDN'T FEEL COMFORTABLE IMPLANTING THE LEAD. THEY OPENED A DIFFERENT LEAD OF THE SAME LOT NUMBER AND IT WAS FINE. VISUAL INSPECTION WAS DONE TO DETERMINE IF THE LEAD WAS DAMAGED. A NEW LEAD WITH THE SAME LOT NUMBER WAS OPENED AND IMPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952531 ↗
• MalfunctionSep 22, 2017Bent; Break; Human-Device Interface Problem; Bent; Break; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY. IT WAS REITERATED THAT WHEN THE LEAD WAS PASSED TO THE STERILE FIELD IT BECAME BENT BENT. HOWEVER, THE LEAD NEVER REACHED THE PATIENT. NO PATIENT SYMPTOMS WERE ALLEGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886782 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER ABOUT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD A DIAGNOSIS OF PNEUMOCEPHALUS ON (B)(6) 2017. THE EVENT WAS STATED TO BE RELATED TO THE PATIENT'S IMPLANT PROCEDURE. THE PATIENT WAS SEEN DURING NORMAL ROUNDS AND COMPLAINED OF THE WORST PAIN/HEADACHE THEY HAVE EVER EXPERIENCED. AT THAT TIME DIAGNOSTIC IMAGING (X-RAY, MRI, CT SCAN ETC) WAS PERFORMED AND THE PNEUMOCEPHALUS WAS DISCOVERED, WITH NO OTHER INTRACRANIAL ABNORMALITY. THE PATIENT SPENT A COUPLE EXTRA DAYS IN THE HOSPITAL FOR OBSERVATION. A CT SCAN ON (B)(6) 2017 SHOWED THAT THE PNEUMOCEPHALUS HAD RESOLVED, AND THE PATIENT HAD RECOVERED WITHOUT SEQUELAE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. [REFER TO MANUFACTURER REPORT #2649622-2017-10193 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.]

  Patient problems: Headache; No Code Available; Pain

  MAUDE report 6876774 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER ABOUT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD A DIAGNOSIS OF PNEUMOCEPHALUS ON (B)(6) 2017. THE EVENT WAS STATED TO BE RELATED TO THE PATIENT'S IMPLANT PROCEDURE. THE PATIENT WAS SEEN DURING NORMAL ROUNDS AND COMPLAINED OF THE WORST PAIN/HEADACHE THEY HAVE EVER EXPERIENCED. AT THAT TIME DIAGNOSTIC IMAGING (X-RAY, MRI, CT SCAN ETC) WAS PERFORMED AND THE PNEUMOCEPHALUS WAS DISCOVERED, WITH NO OTHER INTRACRANIAL ABNORMALITY. THE PATIENT SPENT A COUPLE EXTRA DAYS IN THE HOSPITAL FOR OBSERVATION. A CT SCAN ON (B)(6) 2017 SHOWED THAT THE PNEUMOCEPHALUS HAD RESOLVED, AND THE PATIENT HAD RECOVERED WITHOUT SEQUELAE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Headache; No Code Available; Pain

  MAUDE report 6876309 ↗
• MalfunctionSep 18, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR PARKINSON'S DISEASE. IT WAS REPORTED THAT THE LEAD WAS BENT SO IT WAS NOT IMPLANTED AND REPLACED WITH A NEW ONE. THERE WAS NO KNOWN ENVIRONMENTAL / EXTERNAL / PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE EVENT. 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 6872405 ↗
• MalfunctionSep 12, 2017High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE AFTER LEAD IMPLANTATION. THE IMPEDANCES WERE CHECKED TWICE AT 3.0 V AND BOTH TIMES THEY WERE HIGH ON CONTACT 2. THE HCP SWITCHED THE LEAD OUT AND THE IMPEDANCES WERE NORMAL. 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 6857774 ↗
• MalfunctionAug 22, 2017Break; Stretched; Device Operates Differently Than Expected; Break; Stretched; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS STRETCHED AT THE PROXIMAL END WHILE ATTEMPTING TO EXPOSE IT FROM THE POCKET. THE LEAD WAS COMPACTED BACK TO BEST NORMAL SIZE, THEN INSERTED INTO THE EXTENSION RECEIVER. THE IMPEDANCE WAS TESTED AND WAS WITHIN NORMAL LEVELS. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. 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 6811984 ↗

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, 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.