BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 2190261 · Received July 19, 2011

    Report

    Report Number
    1028232-2011-01567
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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

    THIS LEAD DISLODGED AND WAS UNABLE TO BE REPOSITIONED DUE TO SEVERE REGURGITATION AND PT ANATOMY. A COMPETITIVE LEAD WAS IMPLANTED INSTEAD. THIS LEAD HAS BEEN RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization