BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2050218 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03038
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 14, 2007
    Report Date
    February 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL ANALYSIS AND TESTING SHOWED THAT THE ATRIAL SETSCREWS MOVED FREELY, AND A NORMAL IMPEDANCE MEASUREMENT WAS OBTAINED WHEN A MANUAL LEAD IMPEDANCE MEASUREMENT WAS PERFORMED WITH A KNOWN ELECTRICAL RESISTANCE LOAD CONNECTED. 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. DURING SUBSEQUENT ANALYSIS, PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION THAT WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO ITS INCLUSION IN THE (B)(6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION, SECONDARY TO INVESTIGATION OF HIGH ATRIAL LEAD IMPEDANCE MEASUREMENTS. THE HIGH ATRIAL IMPEDANCES WERE ATTRIBUTED TO SETSCREWS THAT WERE NOT ADEQUATELY TIGHTENED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 68 YR 0185| 0085| 4470| H170