BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3140765 · Received May 31, 2013

    Report

    Report Number
    1721279-2013-00081
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE EP LAB TO REMOVE 5 LEADS DUE TO INFECTION. FOUR LEADS CAME OUT WITHOUT INCIDENT. THE FIFTH LEAD, MDT 6944 (TINED) WAS PREPPED WITH AN LLD-EZ. THE PHYSICIAN BEGAN WITH A 14F GLIDELIGHT (GL), AND LASED TO THE SVC BEFORE THE SVC/RA JUNCTION. NO FURTHER PROGRESS COULD BE MADE, SO THE PHYSICIAN UPSIZED TO 16F GL. THE CASE THEN PROGRESSED THROUGH THE SVC/RA TO THE TIP. IN THE RV APEX, THE PHYSICIAN LASED TO THE LAST CENTIMETER. THE PHYSICIAN TRIED TRACTION, BUT WAS UNSUCCESSFUL. HE LASED A LITTLE MORE, THEN APPLIED TRACTION, AND THE LEAD CAME OUT. APPROXIMATELY 1 MINUTE LATER, THE BP DROPPED. HE DETERMINED IT WAS AN EFFUSION IN THE RV. THE LEAD HAD A SIGNIFICANT AMOUNT OF TISSUE ON IT. THE RESCUE DID NOT PROCEED SMOOTHLY, BUT THE PHYSICIAN DID CRACK THE CHEST AND FOUND A PERFORATION OF THE RV APEX, WHICH WAS REPAIRED. THE PATIENT HAD AN IRREGULAR RHYTHM, WHICH COULD NOT BE REGULATED OR CORRECTED. THE PATIENT DIED ON THE TABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241967 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death MDT 6949 LEAD| MDT 6944 LEAD| BS 0184 LEAD| MDT 4296 LEAD| 16F GLIDELIGHT| 14F GLIDELIGHT| CVX-300 EXCIMER LASER: (SN (B)(4))| MDT 5076 LEAD