BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2522829 · Received April 9, 2012

    Report

    Report Number
    2124215-2012-04025
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    July 3, 2007
    Report Date
    March 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE MET EXPECTED LONGEVITY. THE DEVICE WAS PUT THROUGH AND PASSED THERAPY AVAILABILITY TESTING. IT WAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RELIABILITY ASSURANCE LABORATORY IDENTIFIED MEMORY CORRUPTION FROM THE PRESENCE OF A PERSISTENT SEU (SINGLE EVENT UPSET) FROM THE PATIENT'S MONITORING SYSTEM DATA OF THIS IMPLANTED CRT-D DEVICE IN 2007. MEMORY CORRUPTIONS ATTRIBUTED TO A SEU CAN BE CAUSED BY NATURALLY OCCURRING RADIATION OR FROM THERAPEUTIC SOURCES. THE MEMORY CORRUPTION IMPACTED HISTOGRAM AND COUNTER DATA. THIS DOES NOT REPRESENT A PATIENT SAFETY ISSUE AS THE DEVICE WAS CAPABLE OF SENSING AND DELIVERING CRITICAL THERAPY. TO DATE THE DEVICE AND LEAD SYSTEM REMAINS IN-SERVICE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED IN (B)(6) 2012 DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 4470| 4543| 0185| H210