BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1950913 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22797
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE DEVICE WAS DETERMINED TO HAVE MET LONGEVITY PER DEVICE LABELING, AND DETAILED ANALYSIS REVEALED NO ISSUES WITH THE DEVICE THAT MAY HAVE RESULTED IN PREMATURE BATTERY DEPLETION OR ADVISORY BEHAVIOR.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RECENTLY EXPLANTED FOR BATTERY DEPLETION WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ASSOCIATED WITH A BATTERY MEASUREMENT OF 2.63 VOLTS AFTER 27 MONTHS OF IMPLANT. THIS DEVICE IS INCLUDED IN THE (B)(6 )2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) MONTHLY DEVICE FOLLOW-UPS, WITH REPLACEMENT WITHIN 30 DAYS WHEN ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS IS REACHED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    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 72 YR H210| 4470| 0158| 4538