BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 4182549 · Received October 17, 2014

    Report

    Report Number
    1721279-2014-00167
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT TWO LEADS DUE TO CIED SYSTEM/POCKET INFECTION. THE PHYSICIAN PREPPED BOTH LEADS WITH LLDS BUT WAS UNABLE TO EXTRACT THE LEADS DUE TO SEVERE CALCIUM ATTACHING THE LEADS TO THE VESSEL WALL. THE PHYSICIAN ALSO BELIEVED THE PATIENT MAY HAVE A FISTULA (PRE-OP STATUS OF PATIENT) SO TO PREVENT ANY RISK OF INJURY TO THE PATIENT, THE PHYSICIAN DECIDED TO CUT/CAP THE LLDS IN THE LEADS. THE OTHER CUT/CAPPED LLD WILL BE REPORTED UNDER 1721279-2014-00166.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660132 SPECTRANETICS LEAD LOCKING DEVICE LLD EZ DRB SPECTRANETICS CORPORTATION 518-062 FLP14G16A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| MDT 5534 CARDIAC LEAD (IMPL. 204 MO)| SPECTRANETICS GLIDELIGHT LASER SHEATH| SPECTRANETICS LEAD LOCKING DEVICE #2| MDT 5034 CARDIAC LEAD (IMPL. 204 MO)