BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND

    MDR report key: 1652803 · Received April 5, 2010

    Report

    Report Number
    2124215-2010-06687
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    January 4, 2010
    Report Date
    March 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO FROM THE PT'S WIFE THAT THIS PT EXPIRED TWELVE DAYS POST IMPLANT DUE TO A PUNCTURE LUNG WHICH OCCURRED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 4087| 4086| S603