BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL INC

    MDR report key: 2970202 · Received July 10, 2006

    Report

    Report Number
    2970202
    Event Type
    Injury
    Date Received
    July 10, 2006
    Date of Event
    May 24, 2006
    Report Date
    June 14, 2006
    Manufacturer
    ST. JUDE MEDICAL INC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSP FOR REMOVAL OF AN REPLACEMENT OF DEFECTIVE ATRIAL LEAD SECONDARY TO IT BEING FRACTURED. THIS LEAD HAD BEEN IMPLANTED IN (B)(6) 2005 BECAUSE OF SICK SINUS SYNDROME. IT WAS NOTED AT THE TIME OF REMOVAL THAT THE OUTER COIL WAS VISIBLY FRACTURED SEVERAL CENTIMETERS FROM THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL INC ATRIAL LEAD DTB ST. JUDE MEDICAL INC 1488TC/46 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention