BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 677940 · Received January 26, 2006

    Report

    Report Number
    MW1037836
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    January 3, 2006
    Report Date
    January 25, 2006
    Manufacturer
    ST JUDE MEDICAL
    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 PPM IMPLANT. RA PACE/SENSE LEAD PLACED IN RA, HELIX ADVANCED. HOWEVER, UPON ATTEMPTING TO CONNECT LEAD TO PULSE GENERATOR - LEAD CONNECTS - TIP NOTED BENT. HELIX WAS RETRACTED AND LEAD REMOVED. DIFFERENT LEAD PLACED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL PACE/SENSE LEAD DTB ST JUDE MEDICAL 1688TC *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other