BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 674139 · Received January 26, 2006

    Report

    Report Number
    MW1037834
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 25, 2006
    Manufacturer
    SJM
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE - DUAL CHAMBER PACEMAKER IMPLANT. RA LEAD PLACED IN BODY - RA MAPPED WITH PREVIOUS CAPTURE THRESHOLDS. LEAD REMOVED AND INSPECTED. LEAD WAS BENT AROUND 1/2 CM FROM LEAD TIP. LEAD DISCARDED, STERILIZED, RETURNED MFR. THE HELIX WAS NEVER ADVANCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACE/SENSE LEAD DTB SJM 16881C-52 *
    2 ST. JUDE MEDICAL PACE/SCASE LEAD DTB * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR