BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYO/WIRE

    MDR report key: 436820 · Received January 8, 2003

    Report

    Report Number
    436820
    Event Type
    Injury
    Date Received
    January 8, 2003
    Date of Event
    October 1, 2002
    Report Date
    December 20, 2002
    Manufacturer
    ALTO DEVELOPMENT CORP. DBA A&E MEDICAL CORP.
    Product Code
    LDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED BLEEDING FROM A TEAR ON RIGHT ATRIUM AT A PACING WIRE ATTACHMENT SITE AFTER A CORONARY BYPASS PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention