BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2912355 · Received January 11, 2013

    Report

    Report Number
    1721279-2012-00191
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT SIDED CARDIAC LEAD EXTRACTION PERFORMED IN THE EP LAB TO REMOVE 1 LEAD (MDT 4076 RV IN 2010) DUE TO A SENSING AND IMPEDANCE ISSUE WITH THE RV LEAD. THE RA LEAD WAS FUNCTIONING APPROPRIATELY WITH NO PLANNED EXTRACTION. THE LEAD WAS PREPPED WITH A LLD-EZ, SUTURED AND LASING BEGAN ON THE RV LEAD WITH A 12F GLIDELIGHT. MINIMAL BINDING WAS ENCOUNTERED WITH TOTAL LASING TIME OF 8 SECONDS. THE GLIDELIGHT WAS USED IN THE SUBCLAVIAN BUT NOT BEYOND. THE LEAD WAS SUCCESSFULLY EXTRACTED WITH THE LLD (UNKNOWN MODEL NUMBER). DURING THE RE-IMPLANTATION OF THE RV LEAD, IT WAS NOTED THE PATIENT'S OXYGEN SATURATION WAS DECLINING. AFTER THE RV LEAD WAS PLACED, IT WAS OBSERVED ON FLUOROSCOPY THAT THE PATIENT'S LV WAS NOT MOVING. THE CVS WAS CALLED AND PERFORMED A STERNOTOMY IN APPROXIMATELY 30 MINUTES. UPON EXAMINATION, IT WAS NOTED THERE WAS A PERFORATION IN THE RV APEX. THE MD STATED IT APPEARED AS IF THE RV LEAD HAD PERFORATED THE RV AND WHEN THE LEAD WAS EXTRACTED IT CREATED A HOLE. THE PATIENT DID NOT SURVIVE THE RESCUE ATTEMPT AND WITHIN 10 MINUTES AFTER THE STERNOTOMY THE CODE WAS CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17902 LEAD LOCKING DEVICE LLD MFA SPECTRANETICS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death CVX-300 EXCIMER LASER| 12F GLIDELIGHT| MDT 4076 (RV AND RA)