BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 4251834 · Received November 14, 2014

    Report

    Report Number
    1721279-2014-00199
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4).

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT ONE 6949 LEAD. THE PHYSICIAN WAS UNABLE TO EXTRACT THE LEAD SO THE PHYSICIAN CUT AND CAPPED THE LEAD WITH THE LLD INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737116 SPECTRANETICS LEAD LOCKING DEVICE LLD EZ DRB SPECTRANETICS CORPORTATION 518-062 FLP14D14A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other MDT 6949 CARDIAC LEAD (IMPL 108MO)| SPECTRANETICS GLIDELIGHT LASER SHEATH