BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22405250 · Received July 4, 2025

    Report

    Report Number
    3006630150-2025-05179
    Event Type
    Injury
    Date Received
    July 4, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7130830 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6) BATCH: 5003660 UDI: ((B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. CLINICAL SIGNS INCLUDED LOCALIZED REDNESS. ANTIBIOTIC THERAPY WAS INITIATED, AND CULTURES WERE OBTAINED; HOWEVER, RESULTS REMAIN UNAVAILABLE. THE PATIENT HAS SINCE FULLY RECOVERED. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763851 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1416 232143 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention