BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH / LEAD LOCKING DEVICE

    MDR report key: 1616431 · Received February 24, 2010

    Report

    Report Number
    1721279-2010-00003
    Event Type
    Death
    Date Received
    February 24, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 24, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: UNK. PROCEDURE: NO INFO OTHER THAN A PT DEATH DURING A LASER LEAD REMOVAL CASE WAS PROVIDED TO THE MFR. MULTIPLE ATTEMPTS WERE MADE BY THE MFR WITH NO SUCCESS. ANALYSIS: NO DEVICES WERE RETURNED TO THE MFR AS THEY WERE DISPOSED OFF DURING THE CODE. PT'S OUTCOME: PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH / LEAD LOCKING DEVICE SLS / LLD MFA SPECTRANETICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATION 4 EXCIMER LASER