BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2171593 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09789
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. DETAILED ANALYSIS REVEALED A HOLE IN THE VENTRICULAR RING AND THE ATRIAL SEALPLUG. ALL SETSCREWS FUNCTIONED NORMALLY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. 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. ANALYSIS CONCLUDED THE DEVICE BATTERY DEPLETED AS EXPECTED AND THE DEVICE PASSED AUTOMATED ELECTRICAL TESTING, HOWEVER THE HOLES IN THE SEAL PLUGS MAY HAVE CONTRIBUTED TO THE REPORTED NOISE AND OVERSENSING.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SHOULD THIS DEVICE BE RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    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

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF THIS PRODUCT FOR ANALYSIS WAS INTENDED, HOWEVER, THE DEVICE HAS BEEN RECEIVED AT THE POST MARKET QUALITY ASSURANCE LABORATORY.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS LATER, THIS DEVICE WAS REMOVED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THIS DEVICE WAS REMOVED FOR NORMAL BATTERY DEPLETION AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE REVEALED NOISE CAUSING OVERSENSING. THERE WAS NO PACING INHIBITION. THE PATIENT WITH THIS DEVICE IS NOT PACEMAKER DEPENDENT. IN ADDITION, A DISCREPANCY WAS NOTED REGARDING THE BATTERY LONGEVITY. ONE YEAR AGO, LONGEVITY GREATER THAN FIVE YEARS WAS INDICATED. INTERROGATION AT THIS VISIT REVEALED ONE AND ONE/HALF YEAR REMAINING. A TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE AUTOCAPTURE FEATURE PROGRAMMING OPTIONS. THE DEVICE WAS REPROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR MISMATCH| (B)(4)| (B)(4)| 1292