BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2881723 · Received December 20, 2012

    Report

    Report Number
    1721279-2012-00188
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED LEAD EXTRACTION CASE OF A MDT 4195 STARFIX LV PACING LEAD WITH A LLD (UNKNOWN MODEL#) THAT RESULTED IN A CORONARY SINUS PERFORATION. THE PATIENT DID NOT SURVIVE THE SURGICAL RESCUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE LLD (UNKNOWN MODEL#) DRB SPECTRANETICS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death MDT 4195 ATTAIN STARFIX PACING LEAD