BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2162622 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07716
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    February 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED NINE MONTHS LATER FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED THE FOLLOWING MONTH AND UNDERWENT STANDARD ANALYSIS TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACEMAKER-DEPENDENT PATIENT WITH THIS IMPLANTED DEVICE EXPERIENCED APPROXIMATELY 12 SECONDS OF PACING INHIBITION DUE TO OVERSENSED ELECTROMAGNETIC INTERFERENCE (EMI) NOISE WITHIN HIS HOME. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING TECHNIQUES TO TRY TO IDENTIFY THE SOURCE OF EMI. IT WAS NOTED THAT THE INTERFERENCE IS NOT ABLE TO BE REPRODUCED AT THE CLINIC. FURTHER INVESTIGATION REVEALED THAT THERE IS EMI SOMEWHERE IN THE PATIENT'S HOME. AN ELECTRICIAN WENT OUT TO THE HOME, HOWEVER NO UPDATES WERE MADE TO THE HOME. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THERE WILL BE NO RESOLUTION AND THE PATIENT AND PHYSICIAN ARE AWARE THAT THIS ISSUE WAS NOT CAUSED BY THE DEVICE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    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 85 YR H175| 0158| 4518| (B)(4)| 4087| 4524| 7076