BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYO/WIRE

    MDR report key: 99582 · Received June 20, 1997

    Report

    Report Number
    2242056-1997-00001
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    May 17, 1997
    Report Date
    June 19, 1997
    Manufacturer
    ALTO DEVELOPMENT CORP. A&E MEDICAL
    Product Code
    LDF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE REMOVAL OF TEMPORARY PACING WIRE, CARDIAC TAMPONADE OCCURRED RESULTING IN NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYO/WIRE Implant TEMPORARY CARDIAC PACING WIRE LDF ALTO DEVELOPMENT CORP. A&E MEDICAL NA 0260A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability