BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE RIGHT VENTRICULAR LEAD

    MDR report key: 1050161 · Received May 14, 2008

    Report

    Report Number
    MW4004344
    Event Type
    Other
    Date Received
    May 14, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 9, 2008
    Manufacturer
    ST. JUDE MEDICAL WORLD H.A.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD PACEMAKER IMPLANT IN 2007 FOR CHRONIC A-FIB AND BRADY/TACHY SYNDROME. RECENTLY HAD SYMPTOMS CONSISTENT WITH EXTRA CARDIAC STIMULATION-WAS NOTED TO HAVE DISLODGEMENT OF RIGHT VENTRICULAR LEAD. RIGHT VENTRICULAR LEAD WAS EXPLANTED AND A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED. THE TIP OF THE DISLODGED LEAD WAS FOUND TO BE IN THE RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE RIGHT VENTRICULAR LEAD VENTRICULAR LEAD DTB ST. JUDE MEDICAL WORLD H.A. 1688TCI-52 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other