BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2913248 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17263
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    PMA / PMN Number
    P910077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY ANALYSIS WAS FIRST PERFORMED ON A DIFFERENT PROGRAMMER TO USE AS A COMPARISON. THE PROGRAMMER WAS USED ALONG WITH SALINE TANK AND THE ISSUE THE ATRIAL CHANNEL WAS ABLE TO BE DUPLICATED WITH AN OPEN LEAD. THEN ANALYSIS WAS PERFORMED WITH THIS RETURNED PROGRAMMER AND THE ASSOCIATED DEVICE. A SALINE TANK WAS USED AND ANALYSIS WAS ABLE TO PERFORM ATRIAL LEAD IMPEDANCE MEASUREMENTS USING RADIO-FREQUENCY WITHOUT ANY ISSUE. THE PROGRAMMER AND DEVICE INTERACTION WAS FOUND TO BE FUNCTIONING NORMAL. THIS DEVICE UNDERWENT FURTHER FUNCTIONALITY TESTING AND WAS FOUND TO HAVE MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER WAS USED DURING AN IMPLANT PROCEDURE AND THE FOLLOWING OBSERVATIONS WERE OBSERVED. WHEN THE ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED THERE WAS NON-CAPTURE NOTED ON THE RIGHT ATRIAL CHANNEL ALONG WITH OUT OF RANGE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. IT WAS DETERMINED THAT WHEN WANDED INTERROGATION WAS PERFORMED EVERYTHING WOULD NORMALIZE. POST IMPLANT, THE PATIENT WAS MOVED INTO A DIFFERENT ROOM AND RE-INTERROGATE AND THE SAME OBSERVATIONS WERE OBSERVED WITH THE USE OF RF TELEMETRY. WHEN RF WAS PROGRAMMED OFF EVERYTHING WOULD NORMALIZE. THE NEXT DAY, THE PATIENT WAS INTERROGATED AGAIN WITH A DIFFERENT PROGRAMMER USING WIRELESS AND THERE WERE NO ISSUES OBSERVED. THIS PRODUCT WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19829 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1