BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3043276 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01931
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 3, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    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 HOLES IN THE RA AND RV SEAL PLUGS, WHICH HAD NO IMPACT ON THE CLINICAL OBSERVATIONS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF DEVICE MEMORY FOUND STABLE IMPEDANCE MEASUREMENTS AND VARYING THRESHOLD MEASUREMENTS. ANALYSIS CONCLUDED THAT THE IMPROVEMENT IN LONGEVITY ESTIMATES, FROM LESS THAN 0.5 YEARS IN (B)(6) 2012 TO A LONGEVITY PREDICTION OF ONE YEAR IN THE FOLLOWING (B)(6) 2013, WAS MOST LIKELY DUE TO THE VARIANCE IN PACING THRESHOLD MEASUREMENTS ALONG WITH THE USE OF AUTOMATIC CAPTURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. 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

    BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO FURTHER ALLEGATIONS AGAINST THE DEVICE WERE RECEIVED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER SHOWED A REMAINING LONGEVITY OF LESS THAN 0.5 YEARS AT THE DEVICE CHECK IN (B)(6) 2012. TODAY, THE REMAINING LONGEVITY WAS 1 YEAR. AUTOMATIC CAPTURE WAS PROGRAMMED ON. PACING THRESHOLD MEASUREMENTS RANGED FROM 1.9V TO 2.5V. TECHNICAL SERVICES DISCUSSED THAT AUTOMATIC CAPTURE WAS OPERATING IN RETRY AND REVIEWED THE REASONS THE DEVICE WOULD SWITCH FROM BEAT-TO-BEAT TO RETRY AND HOW THE DEVICE CAN GET OUT OF RETRY BY PERFORMING AMBULATORY THRESHOLD TESTS. IT WAS NOTED THAT RETRY WAS NOT SHOWING IN THE DAILY MEASUREMENTS. LONGEVITY CALCULATIONS WERE RAN AT SEVERAL OUTPUTS, AND TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS TO MAXIMIZE LONGEVITY. IT WAS NOTED THE LEAD WAS A BIFURCATED VDD LEAD AND COULD REMAIN IN USE WITH THE NEXT DEVICE, OR THE RV TERMINAL PIN COULD BE CAPPED IF A NEW RV LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145875 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0882

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0870| 4340| 0882