BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3030702 · Received April 2, 2013

    Report

    Report Number
    1721279-2013-00040
    Event Type
    Death
    Date Received
    April 2, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DETAILS OF THE CASE REPORTED WAS PERFORMED ON (B)(6) 2013 BY SPECTRANETICS. THIS REVIEW DETERMINED THAT THE SUSPECT DEVICE WAS THE LLD#2 THAT WAS USED TO PROVIDED TRACTION TO THE LEAD. THIS FOLLOW-UP REPORT CHANGES THE SUSPECT DEVICE TO THE LLD#2 AS THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE OR TO REMOVE 3 LEADS DUE TO INFECTION. THE FIRST TWO LEADS (MEDTRONIC 5076 AND MEDTRONIC 6957) WERE REMOVED WITHOUT INCIDENT USING A 14F GLIDELIGHT CATHETER. THE FINAL LEAD (MEDTRONIC (B)(4), IMPLANTED (B)(6)) WAS FIXED AT THE RV APEX. THE LEAD WAS PREPPED WITH AN LLD#2. THE PHYSICIAN UPSIZED TO A 16F GLIDELIGHT CATHETER WITH A VISISHEATH AND ADVANCED TO THE LEAD DISTAL TIP. DURING COUNTER TRACTION, THE RV LEAD RELEASED AND WAS REMOVED, BUT THE BLOOD PRESSURE DROPPED. A STERNOTOMY WAS PERFORMED, AND AN RV PERFORATION WAS IDENTIFIED. THE PATIENT DID NOT SURVIVE THE RESCUE ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134733 SPECTRANETICS LEAD LOCKING DEVICE LLD #2 DRB SPECTRANETICS CORPORATION 518-022 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death CVX-300 EXCIMER LASER| MEDTRONIC 4011 LEAD| 16F GLIDELIGHT| VISISHEATH SIZE L (LONG)| LLD #2| MEDTRONIC 6957 LEAD| MEDTRONIC 5076 LEAD