BEUDAMED
    FDA Adverse Event Summary report: N

    PACEMAKER AND LEAD

    MDR report key: 29575 · Received January 29, 1996

    Report

    Report Number
    MW1008218
    Date Received
    January 29, 1996
    Date of Event
    August 24, 1992
    Report Date
    January 26, 1996
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THREE YEARS AGO RPTR HAD A PACEMAKER AND LEAD IMPLANTED. THE DAY AFTER INSERTION PHYSICIAN WENT IN TO TIGHTEN A WIRE. THE NEXT DAY A SCREW WAS TIGHTENED. IN AUGUST RPTR HAD A WIRE REMOVED. FOR 3 YEARS RPTR'S BLOOD PRESSURE WAS 250/170 THE MINUTE SHE GOT OUT OF BED AFTER A NIGHT OF REST AND SLEEP. RPTR BELIEVED THE DEVICE STOPPED WORKING WHEN SHE WAS LYING DOWN. SHE HAD SERIOUS BREATHING RPOBLEMS. ECHOCARDIOGRAMS ARE PERFECT. RPTR HAS NEVER BEEN SICK OR HAD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEMAKER AND LEAD Implant PACEMAKER AND LEAD DXY MEDTRONIC, INC. 7108 402452

    Patients

    Seq Age Sex Outcome Treatment
    1 *