BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1652800 · Received April 5, 2010

    Report

    Report Number
    2124215-2010-06677
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    January 4, 2010
    Report Date
    March 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    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 PUNCTURED LUNG WHICH OCCURRED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND S603

    Patients

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