BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE

    MDR report key: 2771805 · Received September 28, 2012

    Report

    Report Number
    MW5027136
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ST. JUDE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PACEMAKER WIRE INSULATION BREAK CAUSING SENSING PROBLEM. PT HAD FAILURE OF PACING BECAUSE OF IT, AND HAD A SYNCOPAL EVENT CAUSING A FRACTURED HIP. REASON FOR USE: AV BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE PACESETTER VENTRICULAR WIRE DTB ST. JUDE 1388TC

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Other