BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22813618 · Received August 15, 2025

    Report

    Report Number
    3006630150-2025-06537
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7072114, UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7072129, 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. THE PATIENT EXHIBITED PURULENT DRAINAGE AT THE NON-BOSTON SCIENTIFIC LEAD-EXTENSION CONNECTION SITE. CULTURES WERE OBTAINED; HOWEVER, THE RESULTS REMAIN UNDISCLOSED. THE PATIENT IS EXPECTED TO FULLY RECOVER. EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225181 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 504656 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention