BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3211299 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07665
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    June 19, 2013
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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. 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. ELECTRICALLY, THE DEVICE MEETS SPECIFICATION FOR NORMAL BATTERY DEPLETION. IT IS CONCLUDED THAT THE DAMAGE TO THE SETSCREW AND CAPTURE WASHER WAS INDUCED AS IT WAS FOUND THAT THE SET SCREW ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DIFFICULT TO REMOVE. ATTEMPTS WERE MADE TO USE DIFFERENT SCREWDRIVERS, HOWEVER THEY BROKE AND THE SCREW REMAINED STUCK. IT WAS NOTED THAT THE PHYSICIAN WAS NOT USING A BSC SCREWDRIVER.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT THE SET SCREW ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DIFFICULT TO REMOVED. ATTEMPTS WERE MADE TO USE DIFFERENT SCREWDRIVERS, HOWEVER THEY BROKE AND THE SCREW REMAINED STUCK. IT WAS NOTED THAT THE PHYSICIAN WAS NOT USING A BSC SCREWDRIVER. THE ISSUE WAS RESOLVED DURING THE IMPLANT WHEN THE PHYSICIAN FREED ALL THE SETSCREWS BEFORE TRYING TO UNPLUG THE LEADS. THE FROZEN SETSCREW WAS STUCK IN THE UP POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309035 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1