BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS CO LASER

    MDR report key: 374708 · Received February 1, 2002

    Report

    Report Number
    MW1023957
    Event Type
    Death
    Date Received
    February 1, 2002
    Date of Event
    January 22, 2002
    Report Date
    January 31, 2002
    Manufacturer
    SPECTRANETICS CO.
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING REMOVAL OF PACEMAKER LEADS. SPECTRANETICS LASER WITH SPECTRANETICS SHEATH USED TO REMOVE CALCIFIED LEAD. MULTIPLE BURNS ALONG THE INNER WALL OF THE SUPERIOR VENA CAVA. PT TAKEN TO THE OR FOR EMERGENT REPAIR. PERMANENT NEUROLOGIC DAMAGE AND DEATH DUE TO CLAMP TIME FOR EXTENSIVE INJURY REPAIR. AUTOPSY DECLINED. LACERATION WERE FOUND DURING SUERGERY OF THE INNOMINATE VEIN AND SUPERIOR. VENA CAVA LEADS WERE EPICARDIAL LEAD AND INTERNAL CARDIOVERSION DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS CO LASER LASER GEX SPECTRANETICS CO. CVX 300 0

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death SPECTRANETICS SHEATH.