BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041655 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00990
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE IS PENDING.

    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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE MET SPECIFICATIONS IN TESTING AND ANALYSIS. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. BASED ON RECORDED DATA FROM DEVICE OPERATIONS AND AN ENGINEERING CALCULATION BASED ON PROGRAMMED VALUES, THIS DEVICE MET LONGEVITY EXPECTATIONS. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH-VOLTAGE SHOCKING, AND RECORDING FUNCTIONS OF THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI) ASSOCIATED WITH A MIDDLE OF LIFE 2 BATTERY MEASUREMENT AND AN EXTENDED CHARGE TIME THAT EXCEEDED SPECIFICATIONS. THIS DEVICE IS NOT INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION COMMUNICATED (B)(6) 2007. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4470| 5071| 0184| H170