BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELECTRONICS DUAL CHAMBER PACEMAKER

    MDR report key: 30277 · Received February 2, 1996

    Report

    Report Number
    30277
    Event Type
    Death
    Date Received
    February 2, 1996
    Date of Event
    November 30, 1995
    Report Date
    January 31, 1996
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED SEVERE HYPOXIC ISCHEMIC ENCEPHALOPATHY/DEATH DUE TO A VENTRICULAR FIBRILLATION ARREST SECONDARY TO ISCHEMIC CARDIOMYOPATHY AND POSSIBLY INTERNAL CARDIAC PACEMAKER (PM) MALFUNCTION. TRANSCUTANEOUS PM WAS PLACED BY EMERGENCY MEDICAL SERVICES AS THE INTERNAL PM WAS NOT CONTROLLING THE HEART RATE. THE SUSPECT INTERNAL PM HAD BEEN PLACED AT AN OUTSIDE HOSP ON 8/15/91. UNABLE TO DETERMINE IF PT WAS 100% PACEMAKER DEPENDENT. UPON ADMISSION TO FACILITY, INTERROGATION OF THE INTERNAL PM REVEALED THE ATRIAL (A) AND VENTRICULAR (V) LEAD IMPEDANCE WAS >3000 OHMS WITH AMPLITUDE AT 0 VOLTS AND V AMPLITUDE UP TO 7.5 VOLTS WITH PULSE WIDTH UP TO 1.O MS. WITHOUT CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS DUAL CHAMBER PACEMAKER Implant DUAL CHAMBER PACEMAKER DXY TELECTRONICS PACING SYSTEMS REFLEX DDD 8222

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| L