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 Codes	Dizziness (2194); Cognitive Changes (2551); Swelling/ Edema (4577)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Block d.2b: additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45, serial number: (b)(6), batch/lot number: 7145936, model/catalog description: dbs directional lead sterile kit 45cm, unique identifier (udi) #: (b)(4).

• 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: 50003184
• Report Number: 3006630150-2026-05275
• Device Sequence Number: 21486183
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)271216(10)7147048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 7147048
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/19/2026
• Date Device Manufactured: 12/16/2025
• 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 Sex: Female