BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 305657 · Received November 20, 2000

    Report

    Report Number
    MW1020456
    Event Type
    Malfunction
    Date Received
    November 20, 2000
    Date of Event
    November 16, 2000
    Report Date
    November 20, 2000
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S BASELINE HEART RATE IS AROUND 60. DURING SURGERY, WHEN CONNECTED TO MONITOR SYSTEM, PT DEVELOPED A TACHYCARDIA OF 120 WHICH PERSISTED FOR SEVERAL HOURS UNTIL AFTER PT WAS REMOVED FROM THE MONITOR. A NOTIFICATION CONCERNING THIS POSSIBLE EVENT WAS READ ON FDA WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACEMAKER DXY ST JUDE MEDICAL 2102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HEWLETT PACKARD MONITOR 11/18/00.