BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2162164 · Received July 7, 2011

    Report

    Report Number
    1028232-2011-01478
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS LIFTING WEIGHT APPROXIMATELY 3 MONTHS POST IMPLANT, WHICH RESULTED IN DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVY BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization