BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCERTO

    MDR report key: 1369521 · Received April 24, 2009

    Report

    Report Number
    MW5010870
    Event Type
    Other
    Date Received
    April 24, 2009
    Report Date
    April 24, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE 2008. A NEW PACEMAKER/DEFIBER - ON THE SAME DAY, THEY ALSO IMPLANTED A LEAD. IT'S TOO BIG. IT BULGES AND IS PROTRUDING. I HAVE A LOT OF DISCOMFORT. I'M GOING TO FACILITY FOR ANOTHER SURGERY, BECAUSE THEY ARE AFRAID THE WIRES WILL COME THROUGH MY CHEST. THE DOCTOR IS GOING TO MAKE THE HOLE IN MY CHEST BIGGER, SO IT WON'T COME THROUGH. I HAVE 3 LEAD IMPLANTS: 1995- NAME GAIGANT (MODEL #4269). LEAD IMPLANTED 2008, MODEL# 694765. LEAD IMPLANTED 2008, MODEL #5071-53. (MITRAL VALVE OPEN HEART SURGERY, BY PASS ABLATION- MODEL # 310C31. SIZE /DIMENSIONS 31MM) RECEIVED IN 2008. THEY DON'T WANT THE WIRES TO COME THROUGH MY CHEST. THEY SAID I COULD GET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO DEFIB ICD NIK MEDTRONIC C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR