BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20967865 · Received December 18, 2024

    Report

    Report Number
    3006630150-2024-08858
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6) AND BATCH: 7095273. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6) AND BATCH: 7102626. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: (B)(6) AND BATCH: 28387114.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE LEAD EXTENSIONS WHEREIN SHOWING THE PRESENCE OF A BUMP. THE PATIENT WAS ADMINISTERED A SIX-WEEK COURSE OF ANTIBIOTICS. THE INFECTION DID NOT RESOLVE, AND THE HARDWARE BECAME EXPOSED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022682 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1416 207035

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention