BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYO/WIRE

    MDR report key: 155895 · Received March 12, 1998

    Report

    Report Number
    2242056-1998-00002
    Event Type
    Death
    Date Received
    March 12, 1998
    Date of Event
    February 24, 1998
    Report Date
    March 11, 1998
    Manufacturer
    ALTO DEVELOPMENT CORP.
    Product Code
    LDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TAMPONADED FOLLOWING PACING WIRE REMOVAL DUE TO ATRIAL TEAR. CPR REVIVED PT, SUBSEQUENT SURGERY WAS PERFORMED TO REPAIR ATRIAL TEAR. THE SURGERY ALSO REVEALED A LEFT VENTRICLE PUNCTURE OCCURRED AS A RESULT OF THE CPR WHICH SUBSEQUENTLY CAUSED THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYO/WIRE Implant TEMPORARY CARDIAC PACING WIRE LDF ALTO DEVELOPMENT CORP. NA 0281A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death