BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACESETTER

    MDR report key: 277056 · Received April 28, 2000

    Report

    Report Number
    277056
    Event Type
    Injury
    Date Received
    April 28, 2000
    Date of Event
    April 20, 2000
    Report Date
    April 28, 2000
    Manufacturer
    PACESETTER ST JUDE MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD ONSET OF CHEST PAIN AT 2030 HRS ON 4/19/2000. PERSISTED, UNRESOLVED; CALLED AMBULANCE AT 0300 ON 4/20/2000. THEY FOUND PT IN WIDE COMPLEX TACHYCARDIA AT A RATE OF 170. TO ER. UNRESPONSIVE TO LIDOCAINE/SHOCK/OTHER ANTI-ARRHYTHMICS. DETERMINED TO BE PACEMAKER MEDIATED ("RUNAWAY PACEMAKER"). PACEMAKER UNRESPONSIVE TO TELEMETRIC COMMAND TO TURN OFF. COULD TEMPORARILY PROGRAM RATE DOWN. AT 1100 ON 4/20/2000, PT HAD CARDIAC ARREST (V. FIB) AFTER RECURRENT PACEMAKER TREATED TACHYCARDIA. WAS ABLE TO FINALLY DISABLE PERMANENT PACEMAKER BY "X'ING" OUTPUT, ONCE TEMPORARY TRANSVENOUS PACER PLACED. SUSTAINED TACHYCARDIA FOR HOURS RESULTED IN MYOCARDIAL INFARCTION; SUBSEQUENT CARDIAC ARREST. DEVICE DISABLED. THEN REMOVED & REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACESETTER VVI-R SINGLE CHAMBER PACEMAKER DXY PACESETTER ST JUDE MEDICAL 2002T *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R REPLACEMENT PACEMAKER IMPLANTED 4/21/2000.