BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYO/WIRE

    MDR report key: 967106 · Received June 22, 2006

    Report

    Report Number
    2242056-2006-00001
    Event Type
    Death
    Date Received
    June 22, 2006
    Date of Event
    April 17, 2006
    Report Date
    June 19, 2006
    Manufacturer
    ALTO DEVELOPMENT CORP. D/B/A A& E MED CORP
    Product Code
    LDF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MYOCARDIAL BLEEDING OR DAMAGE ESPECIALLY DURING REMOVAL OF THE PACING WIRE IS A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF THIS PRODUCT.

    Description of Event or Problem · 1

    TRANSMURAL PERFORATION OF RIGHT VENTRICULAR WALL FOLLOWING REMOVAL OF TEMPORARY CARDIAC PACING WIRES, POST OPERATIVE DAY 5, CABG SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYO/WIRE TEMPORARY CARDIAC PACING WIRE LDF ALTO DEVELOPMENT CORP. D/B/A A& E MED CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death