BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1863653 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15647
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE MEASURED BATTERY VOLTAGE WAS FOUND TO BE 1.172 VOLTS; ENGINEERING CALCULATIONS CONFIRMED THAT THE DEVICE FELL SHORT OF LONGEVITY EXPECTATIONS BASED ON ACTUAL CLINICAL USE. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN THE DEVICE'S INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTS IN PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED. IT ALSO COULD NOT BE CONFIRMED WHETHER THE DEVICE WAS PACING. IT WAS NOTED THAT THE INTERROGATION ATTEMPT WAS MADE WHILE THE PATIENT WAS IN THE HOSPITAL, AND ON TELEMETRY IT WAS OBSERVED THAT THE PATIENT HAD A COUPLE OF BEATS AT A HEART RATE IN THE 30'S. TECHNICAL SERVICES (TS) RECOMMENDED TRYING TO LISTEN FOR BEEPING WITH MAGNET APPLICATION, AND PERFORMING AN X-RAY TO CONFIRM IT IS A BOSTON SCIENTIFIC DEVICE. ADDITIONAL INFORMATION WAS PROVIDED THAT TONES WERE UNABLE TO BE HEARD, AND DESPITE SEVERAL TROUBLESHOOTING ATTEMPTS, THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE IS SCHEDULED FOR REPLACEMENT IN THE NEAR FUTURE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention