BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYO/WIRE

    MDR report key: 5492586 · Received February 23, 2005

    Report

    Report Number
    2242056-2005-00001
    Event Type
    Injury
    Date Received
    February 23, 2005
    Date of Event
    January 18, 2005
    Report Date
    February 14, 2005
    Manufacturer
    ALTO DEVELOPMENT CORP.
    Product Code
    LDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    MYOCARDIAL BLEEDING OR DAMAGE DURING REMOVAL OF THE PACING WIRE IS A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF THIS PRODUCT. THE METHOD OF ATTACHMENT TO THE HEART IS INDEPENDENT OF THE PACING WIRE AND IS SOLELY THE RESPONSIBILITY OF THE USER. TISSUE WAS REMOVED FROM THE HEART AS A RESULT OF THE PACING WIRE BEING PHYSICALLY CONNECTED TO A 3RD PARTY SUTURE EMBEDDED I THE HEART BY THE INSTALLER.

    Description of Event or Problem · 1

    "PATIENT WIRE PULLED AND NOTED TO HAVE TISSUE ON END. WIRE NOTED TO KINK OR KNOT. PATIENT STARTED BLEEDING AND WAS TAKEN BACK TO SURGERY." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYO/WIRE TEMPORARY CARDIAC PACING WIRE LDF ALTO DEVELOPMENT CORP. NA 0448A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention