BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY PACING ELECTRODE CATHETER

    MDR report key: 1150557 · Received August 22, 2008

    Report

    Report Number
    1150557
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 22, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER REMOVAL OF A BARD TEMPORARY PACEMAKER BALLOON ASSISTED ELECTRODE, IT WAS DISCOVERED THAT THE BALLOON WAS MISSING FROM END OF ELECTRODE. NO BALLOON FRAGMENTS WERE FOUND. IT IS POSSIBLE THAT A VERY SMALL BALLOON FRAGMENT WAS RETAINED IN THE HEART OR PULMONARY VASCULATURE. NO UNTOWARD EFFECT OBSERVED AT THE TIME OF ELECTRODE REMOVAL. PATIENT DIED FOUR DAYS LATER FROM MULTIPLE INJURIES SUSTAINED IN MOTORCYCLE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPORARY PACING ELECTRODE CATHETER CATHETER, TEMPORARY PACING LDF C.R. BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR