BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1890013 · Received November 3, 2010

    Report

    Report Number
    2124215-2010-21224
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. THE EXPLANTED DEVICE WAS GIVEN TO THE PATIENT AND HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS ISSUED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BEING PROGRAMMED TO MONITOR ONLY MODE PRIOR TO AN ELECTIVE REPLACEMENT INDICATOR (ERI) DEVICE REPLACEMENT PROCEDURE. THE PATIENT HAD A HISTORY OF HIGH PROGRAMMED PACING OUTPUT SETTINGS, WHICH IS BELIEVED TO HAVE IMPACTED DEVICE LONGEVITY. SUBSEQUENTLY, A PATIENT ADVOCATE CONTACTED BOSTON SCIENTIFIC AND QUESTIONED WHY THE DEVICE DID NOT LAST LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR H215| 1290| 4456| N118| 4086| 0157| 4525