MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE? CARTESIA?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-2202-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cognitive Changes (2551)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to boston scientific for analysis; therefore, the reported complaint was not able to be confirmed.A review of the device history record (dhr) confirmed the device met all specifications prior to shipping, with no manufacturing deviations identified that could have contributed to the reported event.The product labeling indicates that the following may be potential risks associated with the use of vercise deep brain stimulation systems: "confusion or problems with attention, thinking, or memory".A review of available clinical information and assessment of investigation activities determined that there is sufficient evidence to attribute the reported delayed recovery, cognitive impairment, and need for supportive medical management to factors associated with the surgical procedure, as the treating physician indicated the procedure contributed to the patients condition and no device malfunction or performance issue was identified.Additionally, the clinical course, including delayed recovery and requirement for supportive care, is consistent with post-operative effects rather than device-related issues.Therefore, in the absence of device return and analysis, the reported event is considered to be procedure related.Block d.2b; additional applicable product codes: nhl, pjs.
Event or Problem Description
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 to a skilled nursing facility and continued to recover at the time of the latest report.

• Brand Name: VERCISE? CARTESIA?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25595757
• Report Number: 3006630150-2026-04323
• Device Sequence Number: 17488327
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)271217(10)7147070
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7147070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 12/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female