BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 2081392 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00945
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 18, 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 WAS IMPLANTED AND WHILE THE PT WAS IN RECOVERY THIS LEAD WAS FOUND TO BE DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION THIS LEAD, BUT THE STYLET WOULD NOT ADVANCE PAST THE CONNECTOR PIN, SO THIS LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG, 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization