BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2161640 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08094
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE HOME MONITORING SYSTEM DETECTED THAT THE VENTRICULAR TACHYCARDIA MONITOR PLUS THERAPY MODE WAS TURNED OFF FOR AN UNKNOWN REASON. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    FURTHER INFORMATION CONFIRMED THE DEVICE HAD BEEN INTENTIONALLY DEACTIVATED BECAUSE THE PATIENT WAS IN HOSPICE CARE. THE PATIENT HAD DIED SEVERAL DAYS AFTER THE REPORT THAT THE DEVICE WAS DEACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| O 4518| H229| 7271| 6940| 6942| E030