BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 17851145 · Received October 2, 2023

    Report

    Report Number
    3006630150-2023-05954
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5154855. . PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5143311.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING EDEMA, INFLAMMATION AND REDNESS AT THE IMPLANT SITE. THE PHYSICIAN EXPLANTED THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341146 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 740498

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention