BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 1841561 · Received September 17, 2010

    Report

    Report Number
    1028232-2010-01903
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 2, 2009
    Report Date
    August 17, 2010
    Manufacturer
    BIOTRONIKE SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE (B)(4). PER FOLLOWING PHYSICIAN'S OFFICE, THIS LEAD EXPERIENCED HIGH THRESHOLDS AND WAS EXPLANTED. A BOSTON SCIENTIFIC LEAD WAS IMPLANTED INSTEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization