BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 1213923 · Received October 13, 2008

    Report

    Report Number
    1721279-2008-00031
    Event Type
    Death
    Date Received
    October 13, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT WAS A FEMALE REQUIRING REMOVAL OF 16 YEAR ATRIAL AND RV LEADS AND NEW ATRIAL AND RV LEADS PLACED. PROCEDURE: USING A 16 FR SPNC CATHETER, THE ATRIAL LEAD WAS REMOVED WITH NO PROBLEM WITH A LASE TIME OF 2 MINUTES. THE MD ELECTED TO USE THE CATHETER WITHOUT A SHEATH TO REMOVE THE RV LEAD. AFTER 9 MINUTES OF LASE TIME THE PATIENT ARRESTED ON THE TABLE. THE CT SURGEON WAS AVAILABLE IMMEDIATELY, HOWEVER RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. A PERFORATION WAS DISCOVERED IN THE RV. THE DEVICE WAS NOT RETURNED TO SPECTRANETICS FOR ANALYSIS, BUT THERE WAS NO INDICATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE MFA SPECTRANETICS CORP. 500-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death SPECTRANETICS CVX-300 LASER