BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY CARDIAC PACEMAKER

    MDR report key: 297303 · Received September 20, 2000

    Report

    Report Number
    297303
    Event Type
    Injury
    Date Received
    September 20, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 23, 2000
    Manufacturer
    PACE MEDICAL INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLACK NEGATIVE INSERTION CONNECTION ON PACER BOX CAME OFF. PT WENT TO ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPORARY CARDIAC PACEMAKER TEMPORARY CARDIAC PACEMAKER DXY PACE MEDICAL INC EV4543SN *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention IV PUMP.