BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2031662 · Received March 18, 2011

    Report

    Report Number
    1721279-2011-00013
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 24, 2011
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD REMOVAL CASE PERFORMED IN 2010 INVOLVING A PATIENT DEATH. NO DEVICE, PATIENT OR PROCEDURAL DETAILS ARE AVAILABLE AT THIS TIME. MULTIPLE, UNSUCCESSFUL REQUESTS (02/24/11, 03/09/11, 03/14/11, 03/15/11) HAVE BEEN MADE FOR FURTHER DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II SLS II MFA SPECTRANETICS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death CVX-300 EXCIMER LASER SYSTEM (B)(4)