BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE 1888

    MDR report key: 3221722 · Received July 5, 2013

    Report

    Report Number
    MW5030827
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ST JUDE
    Product Code
    DTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVIDENCE OF ATRIAL LEAD NOISE WITH DEVICE MANIPULATION/L ARM MOVEMENT. DURING NOISE ATRIAL IMPEDANCE DROPPED BY 100 OHMS. EVIDENCE OF INAPPROPRIATE MODE SWITCH WITH TRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307254 ST. JUDE 1888 RA LEAD DTD ST JUDE 1888 BCG14543

    Patients

    Seq Age Sex Outcome Treatment
    1