BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC (REPROCESSED BY STERILMED, INC)

    MDR report key: 752614 · Received May 11, 2005

    Report

    Report Number
    MW1035450
    Event Type
    Injury
    Date Received
    May 11, 2005
    Date of Event
    April 29, 2005
    Report Date
    May 4, 2005
    Manufacturer
    STERILMED, INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR WAS ATTEMPTING TO INSERT A LIFEPORT INTO HIS PATIENT. USING A REPROCESSED INTRODUCER. AS HE ATTEMPTED TO INSERT THE INTRODUCER INTO THE PATIENT, THE INTRODUCER CRUMBLED INTO SEVERAL PIECES.

    Description of Event or Problem · 1

    DR WAS ATTEMPTING TO INSERT A LIFEPORT INTO HIS PATIENT. USING A REPROCESSED INTRODUCER. AS HE ATTEMPTED TO INSERT THE INTRODUCER INTO THE PATIENT, THE INTRODUCER CRUMBLED INTO SEVERAL PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC (REPROCESSED BY STERILMED, INC) INTRODUCER SOLO-TRAK PERCUTANEOUS LEAD 9FR DYB STERILMED, INC PART# MED6209TRK-5 205518

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention