MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise? Cartesia?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-2202-45
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Stroke/CVA (1770); Shaking/Tremors (2515)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximation - based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45, serial number: (b)(6), batch/lot number: 7103326, model/catalog description: dbs directional lead sterile kit 45cm, unique identifier (udi) #: ((b)(4).
Event or Problem Description
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.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25820935
• Report Number: 3006630150-2026-04950
• Device Sequence Number: 21332049
• Product Code: PJS
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)250401(10)7103377
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2025
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7103377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/02/2023
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Male