BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 3161420 · Received June 4, 2013

    Report

    Report Number
    3161420
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: RIGHT AND LEFT CORONARY ANGIOGRAPHY AND RIGHT ILIOFEMORAL ANGIOGRAPHY. PATIENT HAS A PERMANENT PACEMAKER - ST JUDE MEDICAL MODEL NUMBER 5826. PROGRAMMED IN A DDDR MODE AT 70 BEATS /MINUTE WITH A MAX TRACK OF 120 - UPON CINEANGIOGRAPHY OF THE LEFT MAIN, THE PATIENT APPEARED TO DEVELOP WIDE-COMPLEX TACHYCARDIA FROM A BASELINE OF ATRIAL PACING. A MAGNET PLACED ON THE PACEMAKER SLOWED THE RATE. IT WAS DETERMINED THAT THE PACEMAKER ACCELEROMETER WAS BEING ACTIVATED BY THE CINEANGIOGRAPHY.FOR THE REST OF THE PROCEDURE RECORDED IMAGES ON FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247451 ZEPHYR XL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER LWP ST. JUDE MEDICAL 5826 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR