BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1728849 · Received June 8, 2010

    Report

    Report Number
    1721279-2010-00026
    Event Type
    Other
    Date Received
    June 8, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 8, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: THIS WAS A CASE THAT WAS DISCOVERED DURING A BRIEF CONVERSATION BETWEEN THE SPNC REP AND DR (B)(6) AT (B)(6) THAT REPORTEDLY OCCURRED 'SEVERAL MONTHS AGO'. IT IS UNK AT THIS TIME THE SPECIFIC DETAILS SURROUNDING THE CASE OTHER THAN THERE WERE NO REPORTED MALFUNCTIONS OR COMPLICATIONS RELATED TO SPNC DEVICES FROM THE MD. DEVICE ANALYSIS: NO DEVICES WERE RETAINED FROM THIS PROCEDURE FOR RETURN. SINCE THE SERIAL # IS UNK, A LOT HISTORY FILE REVIEW WAS UNABLE TO BE DONE. THERE WERE NO INDICATIONS FROM THE MD THAT THE SPNC DEVICES MALFUNCTIONED OR MAY HAVE BEEN THE CAUSATIVE FACTOR IN THE PT'S POST-OPERATIVE STATUS. PT STATUS: UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATION 4 EXCIMER LASER