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	Foreign Body Reaction (1868); Impaired Healing (2378); Tissue Irritation (4912)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2024.Block d2b: additional pro code selection that applies to the indication of this device .Additional product(s) in device system: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-1416.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: vercise genus p16 ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: 55cm 8 contact extension.Unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: 55cm 8 contact extension.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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25308387
• Report Number: 3006630150-2026-03546
• Device Sequence Number: 9881266
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)250515(10)7105417
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: 05/15/2025
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7105417
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 05/16/2023
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female