BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 2881725 · Received December 20, 2012

    Report

    Report Number
    1721279-2012-00182
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SPECTRANETICS CORPORATION.
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    THIS CASE WAS A (B)(6) MALE PATIENT UNDERGOING EXTRACTION OF A FRACTURED SJM RIATA 1580 LEAD. A 14F GL AND LLD-EZ WERE USED TO EXTRACT THE LEAD. THE DOCTOR LASED FOR "A FEW SECONDS" BEFORE THE RIATA RELEASED. A DROP IN BLOOD PRESSURE WAS OBSERVED. THE CVS PERFORMED A STERNAL WINDOW, PLACED A CHEST TUBE, AND NOTED AN RV APICAL PERFORATION.THE INJURY WAS A SMALL HOLE THAT DID NOT REQUIRE ANY FURTHER INTERVENTION SUCH AS SUTURING OR OTHER REPAIR. THE WOUND TAMPONADED ITSELF. THE CASE WAS PERFORMED IN THE EP LAB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R GLIDELIGHT| SJM RIATA 1580