BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE

    MDR report key: 1220163 · Received October 26, 2008

    Report

    Report Number
    1220163
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 26, 2008
    Manufacturer
    MEDTRONIC INC. , CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS A HISTORY OF FAMILIAL CARDIOMYOPATHY, FOR WHICH SHE UNDERWENT INITIAL ICD DEVICE IMPLANTATION APPROXIMATELY 1 YEAR AGO WITH ASSISTANCE OF PLASTIC SURGERY. PATIENT SUBSEQUENTLY UNDERWENT MULTIPLE POCKET REVISIONS AS WELL AS LEAD EXTRACTION, NEW LEAD PLACEMENT ON THE LEFT SIDE. DUE TO CONTINUED ONGOING INTRACTABLE POCKET PAIN, SHE IS HERE FOR A POCKET REVISION. INCIDENTALLY FOUND TO HAVE RIGHT ATRIAL LEAD INSULATION BREAK AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTSECURE LEAD, ICD, RA DTB MEDTRONIC INC. , CARDIAC RHYTHM DISEASE MANAGEMENT 3830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR