BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX SR 53

    MDR report key: 1122172 · Received August 15, 2008

    Report

    Report Number
    1028232-2008-00930
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 21, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD WAS REMOVED DUE TO INTERMITTENT LOSS OF CAPTURE AND INTERMITTENT UNDERSENSING. THIS LEAD WAS REPLACED WITH A NEW SETROX S 53.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 PACER LEAD DTB BIOTRONIK, GMBH AND CO. 343083

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization