BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LLD #1

    MDR report key: 1152357 · Received August 21, 2008

    Report

    Report Number
    1152357
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 21, 2008
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST WAS USING SPECTRANETICS LASER LEAD REMOVAL EQUIPMENT LLD#1 AND EXPERIENCED THE SAME PROBLEM WITH THE FIRST THREE DEVICES. EACH CAME APART OR BROKE WHILE IN USE AND WERE NO LONGER FUNCTIONAL AS THE LOCK FAILED TO HOLD TOGETHER. THE DOCTOR ALSO ATTEMPTED THE LEAD REMOVAL WITH A SPECTRANETICS LLD E LASER LEAD REMOVAL DEVICE. THIS DEVICE FAILED TO UNLOCK AND A SMALL PORTION OF IT HAD TO BE LEFT IN THE PATIENT WITHIN THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLD #1 LASER, CARDIAC LEAD REMOVAL SYSTEM MFA SPECTRANETICS * LLD080514B
    2 LLD E LASER, CARDIAC LEAD REMOVAL SYSTEM MFA SPECTRANETICS * LLD080512B

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR