BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10423231 · Received August 18, 2020

    Report

    Report Number
    3006630150-2020-03482
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7072565 AND 7072668. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7074639 AND 7074625.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR, IPG, POCKET AND LEAD EXTENSION SITE. THE SYMPTOMS OF INFECTION WERE SWELLING AND TENDERNESS AROUND THE IPG AND LEAD EXTENSIONS. THE PATIENT UNDERWENT AN EXPLANT OF THE DBS SYSTEM AND WAS PROVIDED ANTIBIOTICS. THE PHYSICIAN BELIEVES THAT THE INFECTION WAS DEVICE RELATED. THE EXPLANTED DEVICES WERE DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884569 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 741776

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention