BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD WIRE

    MDR report key: 1083418 · Received July 20, 2008

    Report

    Report Number
    1083418
    Event Type
    Malfunction
    Date Received
    July 20, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 20, 2008
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS DISLODGED AND REPLACED WITH AN ACTIVE FIXATION LEAD. THE PATIENT HAD A HISTORY OF AN IMPLANTED MEDTRONIC DUAL CHAMBER PACEMAKER 24 DAYS PRIOR, FOR TREATMENT OF SYMPTOMATIC SINUS BRADYCARDIA. DURING FOLLOW-UP, SHE WAS FOUND TO HAVE A DISLODGMENT OF HER TINED RV LEAD. BASED ON THIS, AN RV LEAD REVISION WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD WIRE LEAD, PACEMAKER DTB MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT 5092-52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR