BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10891351 · Received November 24, 2020

    Report

    Report Number
    3006630150-2020-05703
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY : DBS-EXTENSION - QUANTITY OF 4, UPN : (B)(4), MODEL : NM-3138-55, SERIAL : (B)(4), LOT : 7075158, 7072180, 7075160, 5177137.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING AND REDNESS AT THE IPG POCKET SITE INDICATING AN INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS AND HAS FULLY RECOVERED. THE PHYSICIAN ASSESSED THE INFECTION WAS STAPHYLOCOCCUS AUREUS AND THAT THE EVENT WAS NOT DEVICE RELATED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360979 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 742282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention