BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX JT 53

    MDR report key: 2231027 · Received July 19, 2011

    Report

    Report Number
    1028232-2011-01602
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 6, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO TOTAL LOSS OF CAPTURE AND SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 53 PACER LEAD NVZ BIOTRONIK SE & CO KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization