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	Erosion (1750)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-30 serial number: (b)(6) batch/lot number: 7077584 model/catalog description: dbs directional lead sterile kit 30 cm unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 29451506 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 29121400 model/catalog description: suretek burr hole cover kit 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: 50288797
• Report Number: 3006630150-2026-05978
• Device Sequence Number: 9694707
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)240807(10)7094668
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2026

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 Expiration Date: 08/07/2024
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7094668
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/18/2026; 09/16/2026; 09/29/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/08/2026; 09/30/2026; 09/30/2026
• Date Device Manufactured: 08/08/2022
• 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: Unknown