BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 2083544 · Received May 10, 2011

    Report

    Report Number
    2124215-2011-08223
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND ANOTHER MANUFACTURER'S LEADS PASSED AWAY FIVE DAYS AFTER THE IMPLANT PROCEDURE. IT WAS REPORTED THE PATIENT WAS FOUND IN ASYSTOLE AND MAY HAVE EXPERIENCED LOSS OF CAPTURE. THE PATIENT ALSO HAD UNDERGONE SURGERY FOR A TRANSCATHETER AORTIC VALVE IMPLANT AS PART OF A CLINICAL TRIAL SPONSORED BY THE LEADS' MANUFACTURER. THERE WERE NO ALLEGATIONS AGAINST THIS DEVICE. THE PATIENT'S BOSTON SCIENTIFIC FIELD REPRESENTATIVE CONTACTED THE PATIENT'S HEALTH CARE PROVIDERS, BUT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 4076| S606