Vercise™ Cartesia™ DB-2202-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 08714729905271), received between Feb 14, 2018 and Sep 28, 2026 — classified as 1 death, 93 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (13 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 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Pain; Perforation; Purulent Discharge; Unspecified Infection

  MAUDE report 50926040 ↗
• InjuryJun 1, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT THAT IS IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED A FALL RESULTING IN A SERIOUS INJURY TO THE FACE REQUIRING MAXILLOFACIAL SURGERY AND HOSPITALIZATION. THE PHYSICIAN INDICATED THAT THE FALL WAS DUE TO ISSUES WITH HIS BOWELS DUE TO HIS PREEXISTING PARKINSON'S DISEASE AND POOR MANAGEMENT OF MEDICATIONS. MULTIPLE HIGH IMPEDANCES WERE DETECTED ON BOTH LEADS AND A RETURN OF THE PREEXISTING SYMPTOMS DUE TO PARKINSON'S DISEASE, WHICH WERE THOUGHT TO HAVE BEEN DAMAGED BY THE IMPACT OF THE FALL. IMAGING WAS PERFORMED THE LEADS AND LEAD EXTENSIONS AND MIGRATION WAS SUSPECTED, THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT EXHIBIT ANY DAMAGE. THE PATIENT'S SYSTEM WAS REPROGRAMMED, RESTORED ADEQUATE THERAPY AND PROVIDED SYMPTOM CONTROL. IT WAS ALSO NOTED THAT THE PATIENT PRESENTED WITH A RASH ON THEIR HEAD WAS PRESCRIBED ANTIHISTAMINE, AND INFECTED LACERATIONS ON THEIR HANDS FOR WHICH THEY WERE PRESCRIBED ANTIBIOTICS.

  Patient problems: Bacterial Infection; Bone Fracture(s); Fall; Head Injury; Insufficient Information; Laceration(s); Rash

  MAUDE report 25356194 ↗
• InjuryMar 23, 2026Use of Device Problem; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A DBS IMPLANT PROCEDURE AFTER WHICH IT WAS DISCOVERED VIA COMPUTERIZED TOMOGRAPHY (CT) IMAGING THAT THE LEAD HAD MIGRATED 8.5 MM. THE PHYSICIAN BELIEVED THAT THE BURR HOLE COVER DID NOT PROPERLY HOLD THE LEAD IN PLACE. THEREFORE, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEAD AND THE BURR HOLE COVER WERE REPLACED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND HAS SINCE RECOVERED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665850 ↗
• InjuryMar 23, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS FEELING UNUSUALLY LOW AND INACTIVE. UPON ADMITTANCE TO THE HOSPITAL, HIGH IMPEDANCE VALUES WERE IDENTIFIED ON BOTH LEADS. REPROGRAMMING OF THE THERAPY WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THESE ELEVATED IMPEDANCE MEASUREMENTS RESULTED IN INADEQUATE STIMULATION, PREVENTING THE PATIENT FROM RECEIVING THE INTENDED THERAPEUTIC BENEFIT FOR PARKINSONS DISEASE. X RAY IMAGING WAS ORDERED TO ASSESS POTENTIAL DAMAGE TO THE LEADS OR EXTENSIONS, THOUGH RESULTS ARE STILL PENDING. THE PATIENT ALSO NOTED A RECENT FALL ON THE LEFT SIDE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) IS LOCATED BUT REPORTED NO DIRECT IMPACT TO THE BATTERY. THE PATIENT REMAINS HOSPITALIZED AS THE ISSUE CONTINUES TO BE INVESTIGATED.ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SYMPTOMS THAT THE PATIENT EXPERIENCED WAS SLOWNESS IN MOVEMENT, INCREASE IN TREMORS AND PAIN RESULTING IN AN INABILITY TO PERFORM HIS DAILY ACTIVITIES. THE X RAY PERFORMED SHOWED NO DAMAGE TO THE LEADS OR LEAD EXTENSIONS. THE PHYSICIAN ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MIGHT BE THE CAUSE OF THE HIGH IMPEDANCES BECAUSE IMPEDANCES ARE SHOWING AT THE SAME CONTACT

  Patient problems: Ambulation or Postural Difficulties; Fall; Fatigue; Insufficient Information; Movement Disorder; Pain; Shaking/Tremors

  MAUDE report 24665772 ↗
• InjuryMar 16, 2026Nonstandard Device

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED A DECUBITUS ULCER AND SKIN EROSION OVER THE BURR HOLE COVER AND LEAD, RESULTING IN THE LEAD BECOMING VISIBLE THROUGH THE SKIN. PURULENT DISCHARGE WAS NOTED AT THE EROSION SITE, RAISING CONCERN FOR INFECTION. THE PATIENT WAS STARTED ON ANTIBIOTICS AND SUBSEQUENTLY UNDERWENT SURGICAL DEBRIDEMENT AND A REVISION PROCEDURE. DURING THE PROCEDURE, THE LEADS WERE PARTIALLY CUT PROXIMALLY AS FAR AS POSSIBLE, AND THE DISTAL PORTIONS WERE REMOVED. THE REMAINING PROXIMAL SEGMENTS OF THE LEADS WERE LEFT IN PLACE AND REMAINED CONNECTED TO THE EXTENSIONS. THE BURR HOLE COVER WAS ALSO EXPLANTED. POSTOPERATIVELY, THE PATIENT RECOVERED WELL. THE PARTIALLY EXPLANTED LEAD SEGMENTS AND BURR HOLE COVER WERE DISPOSED OF BY THE FACILITY AND WERE NOT RETURNED.ADDITIONAL INFORMATION WAS RECEIVED INDICATING A CULTURE WAS TAKEN AND WAS POSITIVE FOR SERRATIA MARCESCENS. THE PHYSICIAN NOTED THAT THE WOUND HEALING DISORDER WAS RELATED TO THE DEVICE DUE TO POSSIBLE PRESSURE ULCER, BUT THE INFECTION WAS NOT.ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PRESENCE OF ANOTHER PRESSURE ULCER THAT WAS OBSERVED BEHIND THE EAR ALONG THE LEAD EXTE

  Patient problems: Bacterial Infection; Erosion; Pressure Sore/Ulcer; Purulent Discharge

  MAUDE report 24613100 ↗
• DeathAug 18, 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 UNDERWENT AN IMPLANT SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A POST-OPERATIVE HEMORRHAGE. DUE TO AN ADVANCED DIRECTIVE IN PLACE, WHICH PROHIBITS LIFE-SAVING SURGICAL INTERVENTIONS, THE PATIENT UNFORTUNATELY PASSED AWAY. THE SURGEON HAS CLEARLY STATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE, AND IT IS UNCERTAIN WHETHER IT WAS RELATED TO THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22835841 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED DELIRIUM. THE PHYSICIAN ATTRIBUTED THIS EVENT TO A MICRO-DESTRUCTIVE EFFECT FOLLOWING LEAD PLACEMENT. AS THE PATIENT WAS ALREADY HOSPITALIZED POST-IMPLANT, HE REMAINED UNDER MEDICAL CARE. THE DELIRIUM HAS SINCE SUBSIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Confusion/ Disorientation; Insufficient Information

  MAUDE report 22031322 ↗
• InjuryApr 3, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON CONTACT EIGHT OF THE RIGHT LEAD WHEREIN CAUSING INADEQUATE STIMULATION AND A RETURN OF DYSTONIA SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE RIGHT LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Movement Disorder

  MAUDE report 21769718 ↗
• InjuryMar 21, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT DURING STAGE ONE OF THE DEEP BRAIN STIMULATION (DBS) IMPLANT, A LOW IMPEDANCE WAS NOTED ON THE LEAD DURING FUNCTIONAL TESTING. ATTEMPTS TO RESOLVE THE LOW IMPEDANCE WERE ATTEMPTED, HOWEVER WERE UNSUCCESSFUL. THE PHYSICIAN OPTED TO KEEP THE LEAD IMPLANTED AND COMPLETED THE PROCEDURE. THE PATIENT UNDERWENT THE SCHEDULED STAGE TWO OF THE DBS PROCEDURE FOUR DAYS LATER WHERE THE LEAD WAS REMOVED AND REPLACED THEREFORE COMPLETING THE SCHEDULED AND ADDITIONAL PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL HOWEVER WAS DISCHARGED SEVERAL DAYS LATER. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665534 ↗
• InjuryNov 1, 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 ENROLLED IN CLINICAL STUDY (B)(6) DEVELOPED BILATERAL DEHISCENCE WOUNDS AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE WOUNDS WERE CLEANED, AND MEDICATION WAS ADMINISTERED. THE EVENT WAS RESOLVING. THIS NON SERIOUS ADVERSE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE HARDWARE OR STIMULATION.

  Patient problems: Wound Dehiscence

  MAUDE report 20588996 ↗
• InjuryAug 22, 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 REDUCED LEVELS OF CONSCIOUSNESS AND HEMIPARESIS AS A RESULT OF A BRAIN BLEED FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE EXCESS BLOOD AND THE LEAD WERE REMOVED. THE PATIENT'S SYMPTOMS IMPROVED AND WAS THEN TRANSFERRED TO A REHABILITATION FACILITY. THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Decreased Level of Consciousness; Intracranial Hemorrhage; Paralysis

  MAUDE report 20044048 ↗
• InjuryAug 14, 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 EDEMA, INFLAMMATION, AND SWELLING, ALONG THE RIGHT LEAD, ONE WEEK AFTER THE IMPLANT PROCEDURE. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED BECAUSE OF NEW ONSET FRONTAL SYNDROME, WHICH REVEALED A LARGE EDEMA AROUND THE RIGHT LEAD THAT HAD NOT BEEN PRESENT AT THE BASELINE CT SCAN. THE SEVERE FRONTAL SYNDROME RELATED TO EDEMA. IT WAS ALSO REPORTED THAT FOREIGN BODY REACTION WAS SUSPECTED. THE PATIENT WAS ALSO TREATED WITH CORTICOSTEROIDS, DEXAMETHASONE AND METHYLPREDNISOLONE, AND THE PATIENT CLINICAL STATUS HAS IMPROVED, AND EDEMA HAS DECREASED. THE PATIENT WAS HOSPITALIZED TWO DAYS LONGER THAN PLANNED.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 19987848 ↗
• InjuryJun 11, 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 MODERATE DELIRIUM THE DAY AFTER THE LEAD IMPLANT PROCEDURE. THE PATIENT WAS TREATED WITH OXYGEN THERAPY AND THE EVENT RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE OR STIMULATION. ANALYSIS OF THE DEVICES WERE NOT CONDUCTED IN OUR LABORATORY, AS THEY REMAIN IMPLANTED AND IN USE IN THE PATIENT.

  Patient problems: Confusion/ Disorientation

  MAUDE report 19515814 ↗
• InjuryJun 3, 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 NORMAL WOUND HEALING FOLLOWING THE IMPLANT PROCEDURE. HOWEVER, WHEN THE LAST SCAB CAME OFF ON HER SCALP, THE LEAD BECAME EXPOSED. THE PHYSICIAN ASSESSED THE LEAD SITE WAS INFECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE SYSTEM WAS REMOVED. THE PATIENT DID WELL POSTOPERATIVELY AND WAS PRESCRIBED ANTIBIOTICS. CULTURES TAKEN WERE POSITIVE FOR STAPHYLOCOCCUS CAPITIS, WHICH WAS REPORTED AS NORMAL SKIN FLORA. THE DEVICES WERE RETAINED BY THE FACILITY; THEREFORE, PHYSICAL ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 19453492 ↗
• InjuryMay 29, 2024Unexpected Therapeutic Results; Communication or Transmission Problem; Migration; Unexpected Therapeutic Results; Communication or Transmission Problem; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED LEAD MIGRATION OF THE LEFT BRAIN LEAD WHEREIN IT WAS NO LONGER AT TARGET POSITION. THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING, RUNNING AND A PROGRESSION OF DYSTONIA SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEFT-BRAIN LEAD WAS REPLACED. THE PHYSICIAN DECIDED TO REPLACE THE RIGHT BRAIN LEAD AS WELL TO ACHIEVE BETTER THERAPEUTIC RESULTS. DURING THE PROCEDURE MONOPOLAR ELECTROCAUTERY WAS PERFORMED. COMMUNICATION BETWEEN THE REMOTE CONTROL AND THE IMPLANTABLE PULSE GENERATOR (IPG) FAILED. AFTER MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE IPG, THE SURGEON DECIDED TO REPLACE THE IPG DUE TO SUSPECTED DAMAGE FROM ELECTROCAUTERY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

  Patient problems: Movement Disorder

  MAUDE report 19415634 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT THE LEAD WAS TEMPORARILY PLACED UNDER THE SCALP. WHILE GENERAL ANESTHESIA WAS ADMINISTERED IN PREPARATION FOR IMPLANTATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) IT WAS OBSERVED THAT THE LEAD HAD PERFORATED THE SKIN. THE PHYSICIAN ADDED SUTURES FOR THE SKIN PERFORATION AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Erosion

  MAUDE report 19213940 ↗
• InjuryApr 5, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A RIGHT LEAD REVISION PROCEDURE DUE TO INSUFFICIENT THERAPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT LEAD WAS REPOSITIONED AND PULLED FOR ABOUT 5 MM.

  Patient problems: Shaking/Tremors

  MAUDE report 19056219 ↗
• InjuryApr 1, 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 NUMBNESS OF THE RIGHT LOWER LIP AND TONGUE FOLLOWING THE IMPLANT PROCEDURE. IN 2021, THE NUMBNESS STARTED TO FEEL LIKE A BURNING SENSATION. THE PATIENT WAS TREATED WITH BOTOX AND HOSPITALIZED.

  Patient problems: Burning Sensation; Numbness

  MAUDE report 19015120 ↗
• InjuryFeb 20, 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) CLINICAL STUDY (A4010 VERCISE DBS REGISTRY) PATIENT DEVELOPED MILD HYPOMANIA SYNDROME AND WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED AND THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT WITH A PROBABLE RELATIONSHIP TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE STUDY DEVICE AND STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE HYPOMANIA EVENT WAS REPORTED AS BEING RELATED TO THE RIGHT LEAD ONLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO DEVELOPED SYMPTOMS OF IMPULSE CONTROL DISORDER AND DELIRIUM. THE PATIENT WAS RECOMMENDED TO FOLLOW-UP WITH OUTPATIENT PSYCHIATRY.

  Patient problems: Confusion/ Disorientation; Emotional Changes

  MAUDE report 18741422 ↗
• InjuryFeb 12, 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 AN INFECTION AT THE LEAD IMPLANT SITE AND UNDERWENT AN EXPLANT OF THE DBS SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 18685280 ↗
• InjuryDec 11, 2023Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE DUE TO LEAD MIGRATION. THE PATIENT EXPERIENCED INADEQUATE THERAPY AS A RESULT OF THE LEAD MIGRATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307527 ↗
• InjuryDec 11, 2023Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE THERAPY DUE TO LEAD MIGRATION OF THE RIGHT LEAD. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306877 ↗
• InjuryNov 27, 2023High impedance; High impedance

  IT WAS REPORTED THAT FOLLOWING A ROUTINE REPLACEMENT OF THE PATIENTS PRIMARY CELL DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG), ONE OF THE PATIENTS LEADS DISPLAYED HIGH IMPEDANCES. THE PATIENT DID NOT EXPERIENCE ANY STIMULATION ISSUES OR PAIN REDUCTION DUE TO THE IMPEDANCES, HOWEVER THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE LEAD AND THE LEAD EXTENSION. THE PATIENT WAS IMPLANTED WITH TWO LEAD EXTENSIONS, AND IT IS NOT KNOWN WHICH ONE WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211800 ↗
• InjuryOct 4, 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 A LARGE LEAD EDEMA A FEW DAYS FOLLOWING THE LEAD IMPLANTATION PROCEDURE. THE EDEMA WAS CONFIRMED VIA COMPUTERIZED TOMOGRAPHY (CT) SCAN TO BE LOCATED ALONG THE LEAD. THE DEVICES REMAINED IMPLANTED, AND THE PATIENT WAS TREATED WITH MEDICATION.

  Patient problems: Swelling/ Edema

  MAUDE report 17874030 ↗
• InjurySep 21, 2023High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE DEEP BRAIN STIMULATION LEAD. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REPLACED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795395 ↗

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