DBS 3387S-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169516540), received between Nov 9, 2016 and Sep 22, 2022 — classified as 1 death, 11 injuries, 12 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  (B)(6) 2022 DTRAK 00022000009546 (HCP): IT WAS REPORTED THAT THE LEAD HAD BEEN IMPLANTED PAST THE USE-BY-DATE (UBD). THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462361 ↗
• InjuryMar 1, 2021High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCES WERE FOUND ON LEFT LEAD AND PATIENT COULD NO LONGER RECEIVE EFFICACIOUS THERAPY. AMPLITUDE TURNED DOWN TO 0 AT TIME OF BATTERY INTERROGATION. LEFT LEAD IMPEDANCES WERE C<(>&<)>0-4 ,364 C<(>&<)>1-4,669 C<(>&<)>2-5,126 C<(>&<)>3-5,101. THE LEFT LEAD DISCONNECTED FROM EXTENSION AND TESTED WITH TWIST LOCK CABLE IN OPERATING ROOM. IMPEDANCES REMAIN HIGH ON TESTING LEAD. LEFT LEAD WAS REPLACED WITH NEW ONE ON (B)(6) 2021. ALL IMPEDANCES WITH IN NORMAL RANGE AND GREEN AFTER NEW LEAD IMPLANTED.

  Patient problems: Dizziness

  MAUDE report 11393556 ↗
• MalfunctionJan 29, 2020High impedance; Material Deformation; High impedance; Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD AN OUT OF RANGE IMPEDANCE AT PRE-OP TESTING FOR A ROUTINE IMPLANTABLE NEUROSTIMULATOR (INS) CHANGE DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE OUT OF RANGE IMPEDANCE WAS AT THE RIGHT GPI LEAD CONTACT 9 AND 11. THE LEFT LEAD WAS STATED TO BE OKAY, WHILE THE RIGHT LEAD HAD THE ISSUE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE KNOWN THAT COULD HAVE LED OR CONTRIBUTED TO THE ISSUE. THE CLINIC WAS INFORMED, ALTHOUGH IT WAS NOTED THEY MIGHT BE AWARE ALREADY, AS THEY ARE NOT USING CONTACT 9 AND 11. THE SURGEON ALSO NOTICED THE RIGHT EXTENSION WAS MORE COILED. THE SURGEON UNCOILED THE RIGHT EXTENSION IN TO THE INS AND DOUBLE CHECKED INSERTION POINTS, HOWEVER THE IMPEDANCES AT CONTACT 9 (34K) AND 11 (HIGH) WERE STILL OUT OF RANGE. THE ISSUE WAS STATED TO BE RESOLVED, AS THE PATIENT WAS PROGRAMMED AROUND THESE TO AVOID AN ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644635 ↗
• MalfunctionJun 1, 2018High impedance; Device Damaged Prior to Receipt by User; High impedance; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATING THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. THE STATUS OF THE AFFECTED LEAD IS UNKNOWN. THIS INFORMATION HAS BEEN CONFIRMED BY THE HEALTHCARE PROVIDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7562722 ↗
• MalfunctionMar 26, 2018Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH IMPLANTED LEADS FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE REP REPORTED THAT THE PATIENT WAS CURRENTLY IMPLANTED WITH A LEAD ONLY SYSTEM. THE REP REPORTED THAT CONTACT 0, BEING THE CONTACT MOST DISTAL, WAS NOT FULLY INSULATED WITH THE BOOT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. [REFER TO MANUFACTURER REPORT #2649622-2018-02745 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.]

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371641 ↗
• MalfunctionMar 26, 2018Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH IMPLANTED LEADS FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE REP REPORTED THAT THE PATIENT WAS CURRENTLY IMPLANTED WITH A LEAD ONLY SYSTEM. THE REP REPORTED THAT CONTACT 0, BEING THE CONTACT MOST DISTAL, WAS NOT FULLY INSULATED WITH THE BOOT. NO PATIENT SYMPTOMS WERE 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 7371611 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT WHEN THE PATIENT HAD THEIR LEADS IMPLANTED, THEY SUFFERED A STROKE CAUSED BY THE SURGERY. THE PATIENT WAS SUPPOSE TO GO HOME AFTER SURGERY IF THEY DIDN'T NICK A BLOOD VESSEL. THE PATIENT ENDED UP BEING IN THE HOSPITAL FOR 3 MONTHS FOLLOWED BY 3 MONTHS. THE PATIENT GOT HOME ON THE (B)(6) OF THIS YEAR. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 7008122 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT WHEN THE PATIENT HAD THEIR LEADS IMPLANTED, THEY SUFFERED A STROKE CAUSED BY THE SURGERY. THE PATIENT WAS SUPPOSE TO GO HOME AFTER SURGERY IF THEY DIDN'T NICK A BLOOD VESSEL. THE PATIENT ENDED UP BEING IN THE HOSPITAL FOR 3 MONTHS FOLLOWED BY 3 MONTHS. THE PATIENT GOT HOME ON THE (B)(6) OF THIS YEAR. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 7008095 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT SAID TO A RESIDENT THAT THEY WERE EXPERIENCING BURNING DOWN THEIR NECK AND JUST WANTED THE SYSTEM REMOVED. THEY ASKED THE DOCTOR TO REMOVE THE SYSTEM. THE REP NOTED THEY WERE NEVER NOTIFIED BUT ASKED IF IMPEDANCES WERE TAKEN TO LOOK AT THE SYSTEM AND THE RESIDENT IN THE PROCEDURE YESTERDAY SAID THAT ALL WAS OKAY THE PATIENT JUST WANTED IT OUT. THE REP WAS UNAWARE OF WHAT THE DOCTOR DID BUT THEY ASKED ABOUT IMPEDANCES AND WAS TOLD ALL THAT WAS DONE AND THE PATIENT JUST WANTED IT OUT. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE ANTICIPATED.

  Patient problems: Burning Sensation

  MAUDE report 6969320 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE REP REPORTED THAT THE PATIENT HAD STROKES AFTER THE LEADS WERE PLACED. THE REP REPORTED THAT THE PATIENT HAD RISK FACTORS FOR STROKE. THE REP REPORTED THAT THE CHECKS ON THE SYSTEM SHOWED THAT IT WAS NORMAL. NO DEVICE ISSUES WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 6903776 ↗
• DeathJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMORS AND FOR PARKINSON'S DISEASE. IT WAS REPORTED FOLLOWING IMPLANTATION OF THE DBS SYSTEM, THE PATIENT WAS STARTED ON LEVNOX FOR ANTICOAGULATION DUE TO HIS MECHANICAL AORTIC VALVE. ON (B)(6) 2017 THE PREVIOUSLY REPORTED SMALL, RIGHT SUBDURAL HEMATOMA (SDH) WAS THOUGHT TO HAVE CAUSED THE PATIENT'S APHASIA AND THEN A SUBSEQUENT FALL. IT WAS NOTED THE PATIENT DEVELOPED LEFT HEMIPARESIS OVERNIGHT AND CONTINUED TO HAVE PROGRESSIVE DECLINE. REPEAT IMAGING WAS LARGELY UNREVEALING. THE PATIENT'S PRIMARY DIAGNOSIS WAS COMPRESSION OF THE BRAIN. SECONDARY DIAGNOSIS INCLUDED CEREBROVASCULAR ACCIDENT, HYPERTENSION, HYPOXIA, SINUS TACHYCARDIA, MECHANICAL AORTIC VALVE, SUBDURAL HEMATOMA, SEIZURE, ELECTROLYTE ABNORMALITIES, MALNUTRITION, AND SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. A CT SHOWED INCREASED RIGHT PNEUMOCEPHALUS AND PREVIOUSLY REPORTED RIGHT SDH. ALONG WITH THE PREVIOUSLY REPORTED SDH/CEREBRAL EDEMA, VENOUS INFARCTION WAS SUSPECTED. DURING THAT 24 HOURS, THE PATIENT CONTINUED TO REQUIRE AGGRESSIVE NASOTRACHEAL (NT) SUCTIONING MORE THAN ONCE AN HOUR DUE TO HEAVY SEC

  Patient problems: Bacterial Infection; Cognitive Changes; Complaint, Ill-Defined; Confusion/ Disorientation; Dysphasia; Edema; Electrolyte Imbalance; Fatigue; Fever; Hematoma; Hemorrhage, Subarachnoid; Hemorrhage, Subdural; High Blood Pressure/ Hypertension; Hyperglycemia; Hypoxia; Infarction, Cerebral; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Neurological Deficit/Dysfunction; No Code Available; Paralysis; Pulmonary Edema; Respiratory Distress; Seizures; Sepsis; Shaking/Tremors; Stroke/CVA; Tachycardia; Unspecified Infection; Urinary Tract Infection

  MAUDE report 6654255 ↗
• MalfunctionJun 14, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING SURGERY THE STIMLOC'S PROFILE WAS FOUND TO BE RAISED ABOVE THE PATIENT'S SKULL AND CREATED HORNS WHICH WERE AESTHETICALLY NOT PLEASE TO THE PATIENT BECAUSE THEY WERE BALD. THE HCP USED A SMALL DRILL TO RECESS THE STIMLOC BY GRINDING THE BONE AROUND THE BURR SO THAT THE STIMLOC SAT DOWN A LITTLE AND WAS LEVEL WITH THE SKULL, THIS TOOK AN EXTRA 20 MINUTES OF PROCEDURE TIME FOR THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 6640033 ↗
• MalfunctionJun 9, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. IT WAS REPORTED THE DISTAL TIP OF THE LEAD WAS SLIGHTLY BENT UPON OPENING FROM A NEW PACKAGE. THE LEAD WAS REPLACED WITH A NEW LEAD PRODUCT, SAME LOT AND MODEL. 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 6630835 ↗
• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT WHO HAD A LEAD IMPLANTED FOR PARKINSON'S DUAL MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT UNDERWENT STAGE ONE PROCEDURE WITH NO ISSUES, AND A CLEAN POST-OP CT SCAN. A WEEK LATER THE PATIENT RETURNED FOR IMPLANT ON THE OTHER SIDE WHEN THE PLANNING SCAN FOUND AN ABSCESS AROUND THE LEAD EVEN THOUGH THE WOUND HAD HEALED. INSTEAD OF IMPLANTING THE OTHER LEAD, THEY REMOVED THE INFECTED LEAD. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 6607825 ↗
• MalfunctionJun 1, 2017High impedance; Device Operates Differently Than Expected; High impedance; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A STIMLOC LEAD. IT WAS REPORTED THERE WAS A HIGH IMPEDANCE FOR CONTACT 0 ON THE LEAD WHEN USING AN ALLIGATOR CLIP TO CHECK DURING AN IMPEDANCE READING. THE CONTACTS 1, 2, AND 3 WERE ALL WITHIN NORMAL RANGE AND COULD INCREASE IN AMPLITUDE WITHOUT ERROR. THE IMPEDANCE ON CONTACT 0 WAS REPORTED TO BE 3043 OHMS. WHEN THE INTEROPERATIVE TESTING WITH AN ENS WAS PERFORMED CONTACT 0 WOULDN'T EXCEED 2.5 BUT THE REST OF THE CONTACTS PERFORMED WITHOUT A PROBLEM. THE LEAD WAS REPLACED WITH ANOTHER LEAD FROM THE SAME LOT AND ALL THE IMPEDANCES WERE REPORTED TO BE WITHIN NORMAL RANGE AND NO FURTHER PROBLEMS OCCURRED WHEN INCREASING THE AMPLITUDE DURING TESTING. 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 6604572 ↗
• InjuryMay 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) THE CONSUMER WAS BALD, SO DURING THE IMPLANT PROCEDURE THE ¿STIMLOC. RAISES WERE ABOVE THE SKULL TOO FAR.¿ THERE WERE NO DIAGNOSTICS OR TROUBLESHOOTING PERFORMED RELATED TO THE ISSUE. IN ORDER TO RESOLVE THE ISSUE THE HCP USED A DRILL TO GRIND THE SKULL DOWN A BIT IN ORDER TO RECESS THE STIMLOC., DOWN INTO THE BONE SO IT DIDN¿T PROTRUDE ABOVE THE SKULL, BUT THE ISSUE STILL WASN¿T RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED. REFER TO MANUFACTURER REPORT #3012165443-2017-00013 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 6582555 ↗
• MalfunctionMay 10, 2017High impedance; High impedance

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6556566 ↗
• InjuryMay 9, 2017High impedance; High impedance

  NO NEW INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555346 ↗
• MalfunctionMay 2, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT A NEW LEAD WAS OPENED AND CONTACT 0 WAS BENT OUT OF BOX. THE SURGEON WOULD NOT IMPLANT THE LEAD, SO A NEW LEAD WAS USED. THE BENT LEAD NEVER TOUCHED THE PATIENT. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6537100 ↗
• InjuryMar 28, 2017Unintended Collision; Unintended Collision

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT WITH A LEAD IMPLANTED FOR PARKINSON'S DUAL MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD A LEAD IMPLANTED FOR PARKINSON'S DUAL MOVEMENT DISORDERS ON (B)(6) 2017. A FEW DAYS AFTER THE LEAD WAS IMPLANTED THE PATIENT HAD A FALL, IN WHICH THEY STATED THEY DID NOT HIT THEIR HEAD. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH APHASIA AFTERWARDS. THE PATIENT HAD A CT BRAIN SCAN AND A SMALL BLEED, AN ¿L HEMORRHAGE¿, WAS OBSERVED AT TWO POINTS ALONG THE PATH OF THE LEAD AT WHICH POINT THE PATIENT WAS ALSO ADMITTED TO THE HOSPITAL. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Dysphasia; Hemorrhage, Cerebral

  MAUDE report 6438657 ↗
• MalfunctionMar 13, 2017Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  A HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE LEAD WAS BENT INSIDE THE PACKAGE ON DATE NOTIFIED. THERE WERE NO ENVIRONMENTAL ISSUES THAT LED TO THE ISSUE AND NO DIAGNOSTICS/INTERVENTIONS PERFORMED. A NEW LEAD WAS USED, RESOLVING THE ISSUE. NO FURTHER COMPLICATIONS ARE ANTICIPATED. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399289 ↗
• InjuryMar 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT EXPERIENCED A BLEED/HEMORRHAGE IN THE BRAIN AS THEY WERE BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS DOING WELL AND WAS RECOVERING. IT WAS STATED THEIR STAGE II PROCEDURE WAS BEING DELAYED UNTIL THEY WERE FULLY RECOVERED. IT WAS NOTED THAT THEY DIDN¿T KNOW ANY ENVIRONMENTAL/EXTERNAL/FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THERE WAS NO TROUBLESHOOTING PERFORMED ALONG WITH NO ACTIONS/INTERVENTIONS TAKEN THAT WERE RELATED TO THE HARDWARE. THE ISSUE WASN¿T RESOLVED AT THE TIME OF THE REPORT, BUT THEY WOULD PROVIDE AN UPDATE WHEN THEY HEARD THE PATIENT WAS SCHEDULED FOR THEIR STAGE II PROCEDURE. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 6376640 ↗
• MalfunctionNov 16, 2016Break; Material Deformation; Break; Material Deformation

  THE HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT WHILE HE WAS PREPARING TO MEASURE THE LEAD FOR IMPLANT, HE NOTICED A SLIGHT BEND IN IT AND DID NOT WANT TO IMPLANT. HE REQUESTED ANOTHER LEAD BE OPENED AND IMPLANTED IT WITH NO ISSUES. THIS OCCURRED ON (B)(6) 2016. THE PATIENT'S INDICATION(S) FOR USE WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6107424 ↗
• InjuryNov 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE EDEMA. IT WAS STATED THAT THE PATIENT'S SYMPTOMS RESOLVED AND THEY DON'T KNOW THE SIGNIFICANCE OF THE MRI CHANGES.

  Patient problems: Complaint, Ill-Defined; Edema

  MAUDE report 6089460 ↗

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-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.