BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FL-601-97-12-B

    MDR report key: 627823 · Received August 4, 2005

    Report

    Report Number
    1056553-2005-00001
    Event Type
    Malfunction
    Date Received
    August 4, 2005
    Date of Event
    July 27, 2005
    Report Date
    August 3, 2005
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN JULY 2005, A POST-OPERATIVE PT DEVELOPED COMPLETE HEART BLOCK AND REQUIRED DDD PACING WITH THE MEDTRONIC TEMPORARY PACING DEVICE. IN THE MORNING, THE ATTENDING PHYSICIAN AND PHYSICIAN ASSISTANTS WERE CALLED TO THE BEDSIDE BY NURSING TO EVALUATE THIS PT AFTER AN EPISODE OF ARRHYTHMIA NEAR SYNCOPE. UPON EXAMINING THE PT, IT WAS FOUND THAT THE PACER WAS LOOSING CAPTURE SECONDARY TO DISLODGMENT OF THE TEMPORARY EPICARDIAL PACING WIRES FROM THE DISPOSABLE TEMPORARY PACING CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FL-601-97-12-B BLUE DISPOSABLE EXTENSION CABLE DSA REMINGTON MEDICAL, INC. FL-601-97-12-B 041602

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R