BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3841677 · Received May 30, 2014

    Report

    Report Number
    1721279-2014-00084
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION PROCEDURE TO REMOVE THREE CARDIAC LEADS FOR A BIV ICD SYSTEM UPGRADE. THE FIRST TWO LEADS (SJM 2088TC RA PACING AND SJM 2088TC RV PACING, BOTH IMPLANTED 14 MONTHS) WERE EXTRACTED SUCCESSFULLY USING AN LLD-EZ AND TRACTION ONLY. THE THIRD LEAD (SJM 1388T RV PACING, IMPLANTED 183 MONTHS) WAS PREPPED WITH AN LLD-EZ AND TRACTION WAS USED TO PULL THE LEAD FREE, HOWEVER THE TIP OF THE LEAD GOT STUCK IN THE SUBCLAVIAN AND COULD NOT BE PULLED FREE THROUGH THE VASCULATURE. THE PHYSICIAN, UTILIZING HIS CLINICAL JUDGMENT, DECIDED TO CUT AND CAP THE LEAD WITH THE LLD STILL INSIDE. THE PHYSICIAN COMPLETED THE DEVICE UPGRADE AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318093 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP13D01B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other ST. JUDE MEDICAL 1388T RV PACING (IMPL 183 MONTHS)| ST. JUDE MEDICAL 2088TC-46 RA PACING (IMPL 14 MON)| SPECTRANETICS LEAD LOCKING DEVICE X2| ST. JUDE MEDICAL 2088TC-52 RV PACING (IMPL 14 MON)