BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 10858611 · Received November 18, 2020

    Report

    Report Number
    3006630150-2020-05612
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(6), MODEL: DB-2202-45, SERIAL: 7073329, BATCH: 7073329.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT RUBBED HER HEAD WITH A BRISTLE BRUSH AND THE SCAB WAS REMOVED, THE PATIENT PRESENTED WITH DRIED BLOOD AT THE SITE AND LEFT LEAD WAS EXPOSED. DUE TO THE WOUND DEHISCENCE THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT OF THE SCALP. THERE WERE NO DEVICES IMPLANTED OR EXPLANTED. THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327608 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5137286 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention