BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 2251830 · Received August 10, 2011

    Report

    Report Number
    1028232-2011-01818
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR- THIS DEVICE WAS EXPLANTED DUE TO LOSS OF CAPTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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 UNK Hospitalization