BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIATURE TEMPORARY CARDIAC PACEMAKER

    MDR report key: 297336 · Received September 20, 2000

    Report

    Report Number
    1218087-2000-00001
    Event Type
    Malfunction
    Date Received
    September 20, 2000
    Date of Event
    August 1, 2000
    Product Code
    DXY
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    BLACK NEGATIVE INSERTION CONNECTION ON PACER BOX CAME OFF. PT WENT TO ASYSTOLE. PACE MEDICAL, INC WAS NOTIFIED BY TODAY'S RECEIPT OF A MEDWATCH FORM, DATED 08/23/2000, COPY APPENDED, OF A CASE IN WHICH IT IS ALLEGED THAT A PT BEING TREATED WITH THE MODEL EV4543 SUDDENLY LOST PACING SUPPORT AS A RESULT OF DETACHMENT OF ITS NEGATIVE TERMINAL. THE PT BECAME ASYSTOLIC NECESSITATING INTERVENTION BY MEDICAL STAFF. NO CLAIM OF INJURY TO THE PT IS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIATURE TEMPORARY CARDIAC PACEMAKER DXY EV4543

    Patients

    Seq Age Sex Outcome Treatment
    1