Vercise™ Cartesia™ DB-2202-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 718 adverse event reports that list this exact device (DI 08714729905288), received between Feb 15, 2018 and Sep 30, 2026 — classified as 18 deaths, 682 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (145 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 718 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Hematoma; Speech Disorder

  MAUDE report 50953427 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  Patient problems: Shaking/Tremors

  MAUDE report 50941504 ↗
• InjurySep 18, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825418 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796865 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with a deep brain stimulation (DBS) system underwent an explant procedure for an unspecified reason. Postoperatively, patient is reported to be at baseline status. Explanted device is unable to return as was disposed of by facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791712 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 50680672 ↗
• InjuryAug 18, 2026Nonstandard Device

  It was reported that during an office follow up visit it was noted that the patient who is implanted with the Deep Brain Stimulation (DBS) leads developed a needle sized dehiscence on the left side but appeared well. While at home the patient experienced convulsions and was hospitalized, Computerized Tomography Scan (CT) imaging was performed, and a strange shape was seen in the results. The patient underwent a revision procedure.It was stated that nothing of note occurred during the procedure that may have contributed to the patient's condition, however, it was noted that the patient has thin skin. During the revision procedure the left lead and left burr hole cover were explanted, however it is unknown which of the two implanted leads or burr hole covers was explanted. Infection was confirmed on the left side, and the patient was prescribed antibiotics. The patient is doing well post operatively, and therapy has been restarted. The devices were retained by the facility.

  Patient problems: Convulsion/Seizure; Unspecified Infection; Wound Dehiscence

  MAUDE report 50291907 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep Brain Stimulation (DBS) patient underwent a lead and burr hole cover explant due to erosion. No additional adverse patient effects were reported. The location of the explanted devices is unknown.

  Patient problems: Erosion

  MAUDE report 50288797 ↗
• InjuryAug 12, 2026Migration

  It was reported that the patient underwent a revision procedure of the right sided lead of the Deep Brain Stimulation (DBS) system, in which the lead was repositioned, during the stage 2 implant due to the lead having migrated following the stage 1 implant which was confirmed with Computerized Tomography Scan (CT) imaging. It is unclear as to which of the two leads was repositioned. We completed a good faith effort to obtain additional information, unfortunately were unable to obtain more information. If additional details become available, a supplemental report will be submitted. No devices will be returned as they remain implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217998 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a scalp rash in the area of the Deep Brain Stimulation (DBS) implant. The patient did not seek medical treatment for several weeks and reportedly concealed the rash with a wig. Upon evaluation by the neurosurgery team, the patient was referred to a dermatologist for further assessment. Dermatologic treatment was initiated and the rash resolved; however, resolution of the rash revealed complete erosion of the overlying skin with full exposure of the burr hole cover. The patient was also reported to be on long-term steroid therapy, which was considered a potential contributing factor due to compromised skin thickness and elasticity. As part of the intervention, the lead and burr hole cover associated with the exposed hardware were explanted. The wound was cleaned, and a plastic surgery team performed closure of the surgical site. Postoperatively, the patient's status was not reported. The explanted devices will not be returned for analysis, as they were disposed of.

  Patient problems: Erosion; Rash

  MAUDE report 50136742 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy; Numbness; Speech Disorder

  MAUDE report 50124577 ↗
• InjuryJul 31, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate stimulation from the leads of the Deep Brain Stimulation (DBS) causing their preexisting symptoms to return. The patient underwent a procedure in which two leads and the burr hole cover were explanted. The patient is doing well post operatively.We completed a good faith effort to obtain additional information, if additional details become available, a supplemental report will be submitted.

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 50107625 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent Deep Brain Stimulation (DBS) implantation and subsequently developed postoperative symptoms suggestive of cognitive dysfunction, as well as dizziness. A computed tomography (CT) scan revealed edema surrounding the implanted electrode. No additional neurological deficits were reported. As part of the intervention, steroid therapy was administered to treat the edema. While the relationship between the edema and the reported symptoms could not be definitively established, the patient's cognitive symptoms and dizziness resolved following treatment. The event did not result in an extension of the original hospital stay. The patient was subsequently discharged from the hospital without reported issues related to treatment.

  Patient problems: Cognitive Changes; Dizziness; Swelling/ Edema

  MAUDE report 50003184 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AT THE LEAD IMPLANT SITE. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO A NON-DBS SURGICAL PROCEDURE PERFORMED NEAR THE LEAD INCISION SITE, WHICH FAILED TO HEAL DESPITE ANTIBIOTIC TREATMENT. AS THE CONDITION DID NOT IMPROVE OVER SEVERAL MONTHS, THE PATIENT WAS ADMITTED AND UNDERWENT A PROCEDURE TO REMOVE THE LEADS. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS AND RECOVERED WELL POSTOPERATIVELY. DEVICE ANALYSIS WAS NOT PERFORMED BECAUSE THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY.

  Patient problems: Bacterial Infection; Impaired Healing; Wound Dehiscence

  MAUDE report 25894152 ↗
• InjuryJul 15, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A NARROW THERAPEUTIC WINDOW ASSOCIATED WITH LEAD POSITIONING; HOWEVER, NO LEAD MIGRATION WAS REPORTED. AS THE PATIENT'S DISEASE PROGRESSED, HIGHER STIMULATION SETTINGS WERE REQUIRED TO ADEQUATELY CONTROL TREMOR SYMPTOMS. FURTHER INCREASES IN STIMULATION AMPLITUDE WERE LIMITED DUE TO SIDE EFFECTS RELATED TO STIMULATION, INCLUDING MUSCLE CONTRACTIONS AND PERSISTENT PARESTHESIA AFFECTING THE HANDS AND FACE. PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, BUT NO SATISFACTORY SOLUTION WAS ACHIEVED. DUE TO THESE ONGOING ISSUES, THE PATIENT UNDERWENT REPLACEMENT OF THE DBS SYSTEM. DURING THE PROCEDURE, THE ORIGINAL BURR HOLES WERE ABANDONED, AND NEW BURR HOLES WERE CREATED TO ALLOW PLACEMENT OF THE LEADS ALONG A DIFFERENT TRAJECTORY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Cramp(s) /Muscle Spasm(s); Paresthesia; Shaking/Tremors; Twitching

  MAUDE report 25830616 ↗
• InjuryJul 14, 2026Unexpected Therapeutic Results; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT STATED THAT THEY HAD EXPERIENCED MULTIPLE STROKES. MEDICAL RECORDS RELATED TO THESE EVENTS WERE NOT AVAILABLE, AND IT IS UNKNOWN WHETHER THE REPORTED STROKES OCCURRED BEFORE OR AFTER IMPLANTATION. THE PATIENT STATED THAT THEY COULD NOT RECALL THE DATES OR DETAILS OF THE REPORTED STROKES. THE PATIENT ALSO STATED THAT THE DBS SYSTEM HAD BEEN TURNED OFF AT THEIR REQUEST AND THAT THEY DID NOT INTEND TO RESUME STIMULATION THERAPY. AS A RESULT OF STIMULATION BEING TURNED OFF, THE PATIENT REPORTED A RETURN OF TREMOR SYMPTOMS. THE DEVICE REMAINS IMPLANTED. ACCORDING TO THE PATIENT, THEY DO NOT WISH TO PURSUE FURTHER MEDICAL TREATMENT.

  Patient problems: Shaking/Tremors; Stroke/CVA

  MAUDE report 25820935 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO EXPERIENCING HALLUCINATIONS, CONFUSION AND PSYCHOSIS A FEW DAYS POST IMPLANT OF THE LEADS FOR THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PHYSICIAN BELIEVES THAT THE INSERTION OF DBS LEAD COULD HAVE BEEN CONTRIBUTORY TO THE EPISODE, BUT NOT NECESSARILY CAUSAL FOR THE EPISODE MENTIONED. IT WAS ALSO STATED THAT NOTHING OF NOTE OCCURRED DURING THE PROCEDURE WHICH MAY HAVE CAUSED THE EPISODE, AND THE CAUSE REMAINS UNKNOWN, AND THAT AN MRI WAS PERFORMED DURING THE HOSPITAL STAY. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL; THERAPY HAS BEEN TURNED ON AND IS STABLE.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Emotional Changes; Psychosis

  MAUDE report 25808463 ↗
• InjuryJul 7, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT THE REPLACEMENT OF THE LEAD AND BURR HOLE DUE TO LOSS OF THERAPEUTIC BENEFITS. DESPITE HIGH STIMULATION IN THE SUBTHALAMIC NUCLEUS (STN), THE PATIENT CONTINUED TO EXPERIENCE TREMOR WITHOUT IMPROVEMENT. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE LEAD WAS POSITIONED APPROXIMATELY 5 MM ABOVE THE INTENDED TARGET. NO PREVIOUS TRAUMA WAS REPORTED. THE DEVICES WERE DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL WITH TREMOR TREATMENT.

  Patient problems: Shaking/Tremors

  MAUDE report 25740458 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEADS AND LEAD EXTENSIONS DUE TO DEVICE EROSION THROUGH THE PATIENT'S SCALP. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. FOLLOWING THE PROCEDURE, THE PATIENT RECOVERED WITHOUT COMPLICATIONS OR REPORTED ADVERSE EFFECTS. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Erosion

  MAUDE report 25728102 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY RECOVERING FOLLOWING STAGE 1 DEEP BRAIN STIMULATION (DBS) SURGERY, INCLUDING COGNITIVE IMPAIRMENT, DELAYED RECOVERY, AND BRADYKINESIA. THE PATIENT INITIALLY REQUIRED NASOGASTRIC (NG) TUBE PLACEMENT FOR MEDICATION ADMINISTRATION AND HAD NOT BEEN DISCHARGED AT THAT TIME; HOWEVER, HER CONDITION IMPROVED, ALLOWING HER TO TOLERATE ORAL MEDICATIONS. SHE WAS NOTED TO BE ALERT WITH MILD DELAYED RESPONSES. THE PATIENT HAD A HISTORY OF ADVANCED PARKINSONS DISEASE, AND IT WAS REPORTED THAT SHE MAY HAVE UNDERLYING MILD COGNITIVE IMPAIRMENT (MCI). IT WAS ALSO NOTED THAT THE PATIENT MISSED DOSES OF LEVODOPA DURING THE RECOVERY PERIOD, WHICH MAY HAVE CONTRIBUTED TO WORSENING PARKINSONS DISEASE SYMPTOMS, INCLUDING BRADYKINESIA. THE PHYSICIAN ASSESSED THAT THE COGNITIVE SYMPTOMS WERE LIKELY RELATED TO ANESTHESIA FROM THE PROCEDURE RATHER THAN THE DEVICE ITSELF. DUE TO THE PATIENTS RECOVERY STATUS, THE PLANNED STAGE 2 PROCEDURE (BATTERY IMPLANTATION) WAS POSTPONED TO ALLOW FOR FURTHER RECOVERY. MEDICAL MANAGEMENT CONSISTED OF SUPPORTIVE CARE, MONITORING, AND CONTINUATION OF PARKINSONS DISEASE MEDICATIONS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED

  Patient problems: Cognitive Changes

  MAUDE report 25595757 ↗
• InjuryJun 10, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) STAGE 1 AND STAGE 2 PROCEDURE, THE PATIENT EXPERIENCED A SEIZURE. DURING ELECTRODE PLACEMENT, WHEN THE PHYSICIAN DRILLED A HOLE IN THE SKULL TO INSERT THE LEFT ELECTRODE, THE PATIENT EXPERIENCED A SEIZURE UPON REMOVAL OF THE DRILL. THE PATIENT WAS ADMINISTERED A DOSE OF PROPOFOL, WHICH STOPPED THE SEIZURE, AND SUBSEQUENTLY RECEIVED KEPPRA AT THE PHYSICIAN'S REQUEST. FOLLOWING TREATMENT, THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN NOTED THAT THE SEIZURE MAY HAVE BEEN RELATED TO EXPOSURE OF THE DURA; HOWEVER, THE EXACT CAUSE IS UNKNOWN. FOLLOWING THE PROCEDURE, THE PATIENT REMAINED IN THE HOSPITAL FOR THREE ADDITIONAL NIGHTS COMPARED TO THE TYPICAL STANDARD OF CARE. THIS EXTENDED STAY WAS PLANNED, AS THE PATIENT IS MUTE, BLIND, AND DEAF, AND THEREFORE REQUIRED ADDITIONAL MONITORING. THE CLINICIAN STATED THAT THE PATIENT'S STAY WAS LONGER THAN TRADITIONAL STANDARD OF CARE, BUT NOT LONGER THAN EXPECTED FOR THIS PATIENT. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 25465729 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED IMPAIRED HEALING AT THE INCISION SITE ON HER SCALP WHICH CAUSED IRRITATION. IT WAS ASSESSED THAT HER BODY WAS REJECTING THE LEADS AND THEREFORE, THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Foreign Body Reaction; Impaired Healing; Tissue Irritation

  MAUDE report 25308387 ↗
• InjuryMay 26, 2026High impedance; Unexpected Therapeutic Results; Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) REVISION PROCEDURE TO REPLACE THE RIGHT-SIDE LEAD DUE TO NON OPTIMAL PLACEMENT AND LACK OF TREMOR CONTROL, A PLASMA BLADE WAS UTILIZED. FOLLOWING THE PLACEMENT OF THE NEW LEAD AN IMPEDANCE CHECK INDICATED ALL CONTACTS WERE OPEN. AFTER FURTHER TROUBLESHOOTING IT WAS DISCOVERED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD BEEN COMPROMISED AND WAS NO LONGER FUNCTIONAL. THE IPG WAS ALSO REPLACED. THE PATIENT WAS DOING WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: Shaking/Tremors

  MAUDE report 25292596 ↗
• InjuryMay 7, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) PROCEDURE, THE PHYSICIAN POSITIONED THE LEAD BASED ON INTRAOPERATIVE TESTING AND IMAGING. ONCE PLACED, THE SURGEON CONFIRMED THE FINAL POSITION. HOWEVER, AT A POSTOPERATIVE IMAGING, REVEALED THAT THE LEAD HAD BEEN MISPLACED, RESULTING IN INADEQUATE STIMULATION. TO CORRECT THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD WAS REMOVED AND REPLACED. FOLLOWING THE REVISION, THE PATIENT MADE A FULL RECOVERY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED.

  Patient problems: Shaking/Tremors

  MAUDE report 25112953 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A STAGE 1 DBS IMPLANT PROCEDURE IN WHICH THE MACHINE FOR ELECTROPHYSIOLOGICAL RECORDING (MER) CAUSED A BLEED IN THE BASAL GANGLIA (BG), SPECIFICALLY IN THE EXTERNAL SEGMENT OF THE GLOBUS PALLIDUS (GPE). SUCTION WAS PERFORMED TO REMOVE THE BLOOD FROM THE CANULA AND STOP THE BLEEDING. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS. POSTOPERATIVELY, COMPUTED TOMOGRAPHY (CT) SHOWED NO EVIDENCE OF BRAIN BLEED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND IT WAS CONFIRMED THAT THEY WERE NOT ADMITTED BEYOND THE STANDARD OF CARE. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25062021 ↗

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