NA DB-2201-45DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729836544), received between Apr 20, 2018 and Sep 30, 2026 — classified as 2 deaths, 51 injuries.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (12 reports).

4 other recalls cover devices cleared under the same FDA submission (P150031); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection, with signs of itching and an open wound, at the lead site of the Deep Brain Stimulation (DBS) system and underwent a revision procedure in which the lead extension was explanted and discarded. The patient is doing well post operatively; the infection has resolved and is undergoing medical treatment.The specific details of the revision procedure are unknown; however, it was stated that the therapy was turned off during the explant procedure, and the patient and family have requested additional assistance obtaining additional therapy.Detailed product information was not provided to BSC for the lead extension, despite having completed a good faith effort to obtain the information. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information. If additional details become available, a supplemental report will be submitted.

  Patient problems: Itching Sensation; Unspecified Infection; Wound Dehiscence

  MAUDE report 50942106 ↗
• DeathJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF A DEEP BRAIN STIMULATION (DBS) LEAD. APPROXIMATELY 36 HOURS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED CLINICAL DETERIORATION. IMAGING VIA CT SCAN REVEALED A LARGE VENOUS INFARCT WITH ASSOCIATED HEMORRHAGE AND CEREBRAL EDEMA. AS A RESULT OF THESE FINDINGS, THE PATIENT UNDERWENT AN EMERGENT RIGHT HEMICRANIECTOMY FOR DECOMPRESSION. THE PATIENT TOLERATED THE PROCEDURE WELL. RETROSPECTIVE INFORMATION OBTAINED FROM THE TREATING INSTITUTION INDICATED THAT THE PATIENT REMAINED HOSPITALIZED FOLLOWING THE PROCEDURE AND WAS LATER REPORTED DECEASED ON (B)(6) 2018, APPROXIMATELY ONE MONTH AFTER THE IMPLANT. ADDITIONAL DETAILS REGARDING THE EVENTS LEADING TO DEATH WERE NOT AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Swelling/ Edema

  MAUDE report 25786370 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST AROUND THE RIGHT BRAIN LEAD IMPLANT, WHICH WAS IDENTIFIED THROUGH IMAGING. ADDITIONALLY, THE PATIENT WAS RECENTLY HOSPITALIZED DUE TO NEW SEIZURES. THE PHYSICIAN WAS UNABLE TO CONFIRM WHETHER THESE SEIZURES WERE CAUSED BY OR RELATED TO THE CYST. THE PHYSICIAN WILL CONTINUE MONITORING THE PATIENT TO DETERMINE IF THE CYST INCREASES IN SIZE.

  Patient problems: Convulsion/Seizure; Insufficient Information

  MAUDE report 24717384 ↗
• InjuryMar 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION AT THE LEAD SITE ON THE LEAD SITE ON THE HEAD OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM AND DISPLAYED SCABBING AND IMPAIRED HEALING. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Erosion; Impaired Healing; Scar Tissue

  MAUDE report 24658896 ↗
• InjuryFeb 17, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION SENSATIONS WHILE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ACTIVE. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN DETERMINED THAT THE PATIENT WOULD BENEFIT FROM A HARDWARE UPGRADE AND LEAD REPOSITIONING. THE PATIENT SUBSEQUENTLY UNDERWENT A PROCEDURE IN WHICH THE EXISTING LEADS AND BURR HOLE COVERS (BHC) WERE REMOVED AND REPLACED WITH A NEW BHC AND DIFFERENT MODEL LEADS PLACED IN AN ALTERNATIVE TARGET. DEVICE ANALYSIS WAS NOT CONDUCTED, AS THE COMPONENTS WERE RETAINED BY THE FACILITY. THE PATIENT RECOVERED WELL FOLLOWING THE PROCEDURE.

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 24372789 ↗
• InjuryDec 15, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT TREATED FOR EPILEPSY, DEVELOPED AN INFECTION AT THE LEAD/LEAD-EXTENSION CONNECTION INCISION BEHIND THE RIGHT EAR. THE PATIENT'S SYMPTOMS INCLUDED PUS AND OOZING AT THE INCISION SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS. CULTURES WERE TAKEN, AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS CONFIRMED. THE PATIENT IS CURRENTLY DOING WELL, WITH NO ADDITIONAL HOSPITALIZATION OR TREATMENT REQUIRED AT THIS TIME. THE DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 23812182 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH REDNESS, SWELLING, AND DEHISCENCE AT THE LEFT CRANIAL INCISION SITE, EXPOSING THE LEAD AND LEAD EXTENSION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DBS LEAD AND LEAD EXTENSION WERE REMOVED DUE TO INFECTION RISK PRIOR TO COMPLETION. THE CAUSE OF THE DEHISCENCE REMAINS UNKNOWN PER PHYSICIAN FEEDBACK. ANALYSIS OF THE LEAD AND LEAD EXTENSION WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND RECOVERED WELL POSTOPERATIVELY.

  Patient problems: Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 23749889 ↗
• InjuryNov 17, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF THEIR PARKINSON'S DISEASE SYMPTOMS, TREMORS, ON THE LEFT SIDE OF THE BODY, NO TRAUMA WAS REPORTED. DUE TO A LACK OF THERAPY FROM THEIR DEEP BRAIN STIMULATION (DBS) SYSTEM. DURING REPROGRAMMING HIGH IMPEDANCES WERE NOTED ON THE LEADS, THERAPY WAS ABLE TO ADDRESS THE PATIENTS' SYMPTOMS BUT NOT AS WELL AS PRIOR TO IDENTIFYING THE IMPEDANCES. IT WAS ALSO STATED THAT THE PATIENT LOST THERAPY, AND THAT IT WAS TAKING LONGER TO CHARGE THE IMPLANTABLE PULSE GENERATOR (IPG). COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AND CONFIRMED THAT THE RIGHT LEAD RETRACTED CEPHALAD TO THE SUBTHALAMIC NUCLEUS (STN) BY APPROXIMATELY TWO INCHES WHICH WAS CONFIRMED AS THE REASON FOR THE PATIENT HAVING LOST THERAPY ON THEIR LEFT SIDE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE SYSTEM WAS EXPLANTED. DEVICE ANALYSIS CANNOT BE CONDUCTED AS THE DEVICES WERE NOT RETURNED.

  Patient problems: Movement Disorder; Shaking/Tremors

  MAUDE report 23572172 ↗
• InjuryOct 3, 2025Off-Label Use; Unexpected Therapeutic Results; Off-Label Use; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE LEADS NOT PROVIDING THERAPY. THE PATIENT IS BEING TREATED FOR CENTRAL PAIN POST-STROKE. THE LEADS WERE REPLACED, AND THE PATIENT IS STILL IN THE HOSPITAL RECOVERING. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY WERE DESTROYED BY THE FACILITY.ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE PATIENT'S INFORMATION AND PRODUCT DETAILS.

  Patient problems: Pain

  MAUDE report 23216118 ↗
• InjuryJul 14, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERGOING DEEP BRAIN STIMULATION (DBS) EXPERIENCED INSUFFICIENT STIMULATION, WHICH ADVERSELY AFFECTED MOBILITY IN HIS LEFT LEG. AS A RESULT, A LEAD EXPLANT PROCEDURE WAS PERFORMED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22500318 ↗
• InjuryApr 29, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO INADEQUATE STIMULATION, AS A RESULT, THE PATIENT EXPERIENCED A RECURRENCE OF TREMORS AS THE THERAPY DID NOT SUSTAIN OVER TIME. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY THE PATIENT WAS RECOVERING WELL, THE PROGRAMMING APPOINTMENT WAS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Shaking/Tremors

  MAUDE report 21927711 ↗
• InjuryApr 24, 2025Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION AND ELECTIVE REPLACEMENT FOR SYSTEM UPGRADE AS A DIRECTIONAL LEAD IMPLANTED TO IMPROVE BENEFITS. THE PATIENT IS DOING GREAT POST OPERATIVELY WITH NO COMPLICATIONS, WAITING FOR NEW LEAD TO BE PROGRAMMED. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY POLICY.

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 21900185 ↗
• InjuryJan 10, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE TREMOR THERAPY CONTROL. SEVERAL ATTEMPTS TO REPROGRAM THE SYSTEM WERE MADE HOWEVER WERE UNSUCCESSFUL. IT WAS NOTED THAT THE INITIAL BILATERAL GPI LEAD PLACEMENT DID NOT PROVIDE ADEQUATE THERAPY AND LEADS WOULD NEED TO BE PLACED IN THE SUBTHALAMIC NUCLEUS (STN) AREA OF THE BRAIN PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS LEADS WERE REMOVED, AND NEW LEADS WERE PLACED IN THE STN AREA. PHYSICAL ANALYSIS OF THE DBS LEADS WAS NOT PERFORMED AS THEY WERE DISCARDED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Shaking/Tremors

  MAUDE report 21123642 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE HEADER BLOCK OF THE LEAD EXTENSION AND UNDERWENT A FULL SYSTEM EXPLANT. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED.

  Patient problems: Erosion

  MAUDE report 20850148 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED PERIELECTRODE EDEMA TWENTY-SEVEN DAYS AFTER THE IMPLANT PROCEDURE AND HAD SYMPTOMS OF DIZZINESS, AND POSTERAL INSTABILITY. THE EDEMA WAS FOUND, WITH COMPUTED TOMOGRAPHY (CT), AROUND THE IMPLANTED ELECTRODE. THE PHYSICIAN SUSPECTED FOREIGN BODY REACTION AND WAS ADMINISTERED DEXAMETASONA. THE PATIENT IS DOING FINE.

  Patient problems: Dizziness; Insufficient Information; Swelling/ Edema

  MAUDE report 19762732 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED PERIELECTRODE EDEMA AFTER THE IMPLANT PROCEDURE AND HAD SYMPTOMS OF DROWSINESS AND LEFT HEMIPARESIS. THE EDEMA WAS FOUND AROUND THE IMPLANTED ELECTODE. A RIGHT FRONTAL PERIELECTRODE HEMATOMA, MARKED LATERAL VENTRICLE COMPRESSION EDEMA. THE PHYSICIAN SUSPECTED FOREIGN BODY REACTION AND THE PATIENT WAS HOSPITALIZED AND ADMINISTERED DEXAMETASONA AND ANTIBIOTRAPIA. THE PATIENT IS UNDERGOING REHABILITATION AND CONTINUES TO HAVE PHYSICAL SEQUELAE ON THE LEFT SIDE.

  Patient problems: Hematoma; Muscle Weakness/Atrophy; Swelling/ Edema

  MAUDE report 19762731 ↗
• InjuryMay 6, 2024Migration; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE DUE TO MIGRATION. DURING THE IMPLANT PROCEDURE, WHILE TUCKING THE LEAD BEHIND THE EAR, THE LEAD PULLED OUT OF POSITION. THE PHYSICIAN ADVANCED THE LEAD BACK INTO THE ORIGINAL POSITION. THE PATIENT WAS DOING FINE POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255584 ↗
• InjuryFeb 5, 2024High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE DYSTONIA COVERAGE. IMPEDANCES WERE OBSERVED AND TWO SURGERIES WERE PERFORMED TO IDENTIFY THE SOURCE OF THE IMPEDANCES. THE PHYSICIAN INITIALLY REPLACED THE LEAD BUT THE IMPEDANCES REMAINED, SO A SECOND REVISION WAS PERFORMED TO REPLACE THE LEAD EXTENSION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

  Patient problems: Movement Disorder

  MAUDE report 18647228 ↗
• InjuryJan 23, 2024Off-Label Use; Unexpected Therapeutic Results; Off-Label Use; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TWO DEEP BRAIN STIMULATION (DBS) LEADS AND AN EXTENSION. THE PHYSICIAN MADE THE DECISION TO EXTERNALIZE THE EXTENSION AND ATTEMPT PROGRAMMING WITH AN EXTERNAL TRIAL STIMULATOR (ETS) TO SEE IF THIS WOULD ADDRESS THE PATIENT'S FACIAL PAIN. POSTOPERATIVE PROGRAMMING WAS NOT ABLE TO RELIEVE THE PATIENT'S PAIN AND THE PATIENT THEN UNDERWENT A PROCEDURE TO REMOVE THE IMPLANTED DEVICES. PHYSICAL ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY, AS THE DEVICES WERE RETAINED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 18567864 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WITH SIGNIFICANT BRAIN ATROPHY AND A DIFFICULT SURGICAL TRAJECTORY UNDERWENT A REVISION PROCEDURE TO HAVE A NEW DBS SYSTEM IMPLANTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 18432976 ↗
• InjuryDec 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED BALANCE AND SPEECH DIFFICULTIES FOLLOWING A STANDARD BILATERAL DEEP BRAIN STIMULATION (DBS) LEAD PLACEMENT, AND A NERVE GRAFT INTO THE SUBSTANTIA NIGRA PARS RETICULATA. AN INVESTIGATIONAL METHOD FOR CANNULA INSERTION WAS USED FOR BOTH THE LEAD PLACEMENT AND THE NERVE GRAFTS, RESULTING IN A TEN-HOUR PROCEDURE. THE PHYSICIAN ASSESSED THAT THE PATIENT'S POSTOPERATIVE SYMPTOMS WERE DUE TO HAVING BEEN UNDER ANESTHESIA FOR A PROLONGED PERIOD OF TIME. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND WAS PROVIDED PHYSICAL THERAPY. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Balance Problems; Speech Disorder

  MAUDE report 18298344 ↗
• DeathNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DROWSINESS AFTER THE IMPLANT PROCEDURE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH A CEREBRAL HEMATOMA. THE PHYSICIAN BELIEVES THE HEMATOMA WAS PROCEDURE RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEDATED AND TREATED IN THE CRITICAL CARE UNIT (UCI) BUT LATER PASSED AWAY.

  Patient problems: Hematoma

  MAUDE report 18061894 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN ASSESSED THAT THE DEEP BRAIN STIMULATION (DBS) LEAD HAD NOT BEEN POSITIONED OPTIMALLY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REVISED AND IS DOING WELL POST-OPERATIVELY. THE LEAD WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239260 ↗
• InjuryMay 25, 2023Migration; Migration

  IT WAS REPORTED THAT SHORTLY AFTER HAVING BEEN IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) LEAD, THE PATIENT EXPERIENCED INADEQUATE STIMULATION. IMAGING CONFIRMED THE RIGHT DBS LEAD MIGRATED. REPROGRAMMING THE DEVICE WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT THEN UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPLACED AND RE-ANCHORED. THERE WAS NO SUSPECTED ISSUE WITH THE LEAD ITSELF AND THE MEDICAL FACILITY DISPOSED OF THE LEAD. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17008072 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN TAKEN IN THE FIELD REVEALED A CLOUDY WHITE AREA, DESCRIBED AS HALATION, AROUND THE RIGHT LEAD OF THE PATIENTS DEEP BRAIN STIMULATION (DBS) SYSTEM. THE CONDITION WAS MONITORED FOR ONE MONTH, BUT THE HALATION DID NOT SUBSIDE. THE CAUSE OF THE HALATION WAS UNKNOWN, BUT THE PHYSICIAN ASSESSED THE PATIENT TO LIKELY HAVE MILD MENINGITIS, AND THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS LEAD WAS REMOVED AS A PRECAUTION. CULTURES WERE TAKEN BUT THE RESULTS WERE NOT PROVIDED. PHYSICAL ANALYSIS OF THE DBS LEAD WAS NOT PERFORMED AS IT WAS RETAINED BY THE FACILITY.

  Patient problems: Meningitis

  MAUDE report 16908313 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• Z-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• Z-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the