BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 1150128 · Received August 29, 2008

    Report

    Report Number
    1028232-2008-01070
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE OOS, THIS PT HAD SEVERAL SHOCKS AND CHARGES FROM THREE DAYS IN 2008. THIS DEVICE WAS OVERSENSING. THIS DEVICE WAS REPLACED WITH A COMPETITOR'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization