BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE

    MDR report key: 6801125 · Received August 17, 2017

    Report

    Report Number
    1721279-2017-00165
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 24, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD EXTRACTION PROCEDURE TO REMOVE AN ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) DEVICE. PHYSICIAN USED A 12F GLIDELIGHT, A 14F GLIDELIGHT AND AN LLD (LEAD LOCKING DEVICE) IN AN ATTEMPT TO REMOVE THE LEAD. HOWEVER, THE LEAD COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO ABANDON THE EXTRACTION, AND CUT AND CAPPED THE LEAD, LEAVING PART OF THE LLD INSIDE THE LEAD. PATIENT SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581935 SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE LLD EZ DRB SPECTRANETICS 518-062 FLP17C07A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R SPECTRANETICS 12F GLIDELIGHT LASER SHEATH| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER