BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1043217 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33437
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    June 7, 2011
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES ADVISED THE NOISE APPEARED CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI). THIS CRT-D WAS REPROGRAMMED TO LEAST SENSITIVITY AND NO FURTHER OVERSENSING HAS BEEN NOTED. THIS LEAD REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT FURTHER OVERSENSING HAS BEEN NOTED. TECHNICAL SERVICES PROVIDED TROUBLESHOOTING RECOMMENDATIONS. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR RESOLUTION TO THIS ISSUE, BUT THEY WERE UNABLE TO PROVIDE ADDITIONAL DETAIL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE REOPENED. THE DEVICE WAS EXPLANTED THREE YEARS LATER FOR NORMAL BATTERY DEPLETION. THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED NOISE ON THE RATE/SENSE CHANNEL WHICH WAS OVERSENSED BY THIS IMPLANTABLE RIGHT VENTRICULAR LEAD RESULTING IN A NON-SUSTAINED EPISODE AND PACING INHIBITION. THE PATIENT DOES NOT RECALL ANY SYMPTOMS RELATED TO THIS ISSUE AND REPORTED BEING ASLEEP AT THE TIME. AN ELECTROGRAM DEPICTING THE NOISE WAS FAXED FOR TECHNICAL SERVICES REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 RF IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other THE DEVICE 4513/405618 WAS IMPLANTED 10-NOV-2005| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 6483 505120 WAS USED DURING THE EVENT.| THE DEVICE 4470/463485 WAS IMPLANTED 10-NOV-2005| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2005| THE DEVICE 6482 000522 WAS USED DURING THE EVENT.| THE DEVICE 6487 505100 WAS USED DURING THE EVENT.| THE DEVICE 0185/130193 WAS IMPLANTED 10-NOV-2005| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2005| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2005