BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 5889709 · Received August 19, 2016

    Report

    Report Number
    1721279-2016-00104
    Event Type
    Injury
    Date Received
    August 19, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 26, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    PROCEDURE TO EXTRACT TWO LEADS, RA AND RV DUE TO CIED/SYSTEM/POCKET INFECTION. THE LEADS WERE BOTH PREPPED WITH LLD'S. THE PHYSICIAN WAS MOVING THE GLIDELIGHT LASER SHEATH OVER THE RA LEAD, A SECOND PASS, ATTEMPTING TO MOVE PAST AN AREA OF OBSTRUCTION. THE LASER WAS NOT ACTIVATED; HOWEVER A PERFORATION IN THE POSTERIOR ASPECT OF THE SVC OCCURRED. THE INJURY WAS SURGICALLY REPAIRED. THE MD STATED THAT NO FURTHER EXTRACTION COULD BE PERFORMED DUE TO SEVERE CALCIFICATION TO THE POINT OF OCCLUSION AT THE RA/SVC JXN. THE TWO LLDS WERE CUT AT THE POINT WERE THEY ENTERED THE LEADS AND CAPPED. THE PATIENT SURVIVED THE PROCEDURE. MDR REPORT FOR GLIDELIGHT; 1721279-2016-00101, 1ST LLD; 1721279-2016-00103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543782 SPECTRANETICS LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-062 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other