BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 274729 · Received April 21, 2000

    Report

    Report Number
    274729
    Event Type
    Death
    Date Received
    April 21, 2000
    Date of Event
    April 8, 2000
    Report Date
    April 19, 2000
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TO OR FOR REMOVAL OF AICD LEAD; SUSTAINED A TEAR/(LACERATION) TO SUPERIOR VENA CAVA AND SUFFERED CARDIOPULMONARY ARREST. PT RESUSCITATED AND TEAR REPAIRED. EXPIRED 48 HRS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EXCIMER LASER GEX SPECTRANETICS CORP CVX-300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death