BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS

    MDR report key: 2911495 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15978
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WEEK, THE REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED. IT WAS DIFFICULT TO REMOVE THE RA AND RV LEADS FROM THE DEVICE HEADER. VISUAL INSPECTION FOUND BLOOD INFILTRATION IN THE RA PORT. THE RV LEAD WAS REMOVED WITH A WRENCH. BOTH LEADS WERE THOROUGHLY TESTED WITH THE PACING SYSTEM ANALYZER (PSA), WITH NORMAL MEASUREMENTS NOTED. BLOOD ON THE TERMINAL PINS WAS CLEANED OFF, AND THE LEADS WERE CONNECTED TO A COMPETITOR'S PACEMAKER. LEAD MEASUREMENTS WITH THE NEW DEVICE WERE WITHIN NORMAL RANGE. THE CHRONIC RA AND RV LEADS REMAIN IN SERVICE WITH THE NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR LABORATORY ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PRODUCT WAS INSPECTED AND A HOLE IN THE DISTAL ATRIAL SEAL PLUG WAS OBSERVED. BODY FLUID CONTAMINATION WAS FOUND IN BOTH THE ATRIAL AND VENTRICULAR LEAD BARRELS. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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. LABORATORY ANALYSIS DETERMINED THAT THE HOLE IN THE ATRIAL SEAL PLUG MAY HAVE CAUSED THE NOISE AND OVERSENSING ON THE ATRIAL LEAD THAT WAS OBSERVED IN THE FIELD. HOWEVER, THE VENTRICULAR SEAL PLUGS WERE INTACT; THEREFORE, THE CAUSE OF THE NOISE AND OVERSENSING ON THE VENTRICULAR LEAD COULD NOT BE DETERMINED. THE BODY FLUID WITHIN THE LEAD BARRELS LIKELY CONTRIBUTED TO THE DIFFICULTY IN REMOVING THE LEAD TERMINAL PINS FROM THE DEVICE HEADER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER AND LEAD SYSTEM WAS TAKEN BY AMBULANCE TO THE HOSPITAL, DUE TO LOSS OF CONSCIOUSNESS. THE DEVICE CHECK REVEALED INTERMITTENT OVERSENSING ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. LEAD IMPEDANCE, THRESHOLD, AND SENSING MEASUREMENTS WERE WITHIN NORMAL RANGE. NOISE ON BOTH LEADS WAS OBSERVED ON THE ECG MONITOR. THE PACING CONFIGURATION WAS REPROGRAMMED TO AAT. THE FOLLOWING DAY, THE DEVICE WAS CHECKED AGAIN, WITH THE SAME INTERMITTENT OVERSENSING AND NOISE NOTED. LEAD MEASUREMENTS WERE GOOD. A REVISION PROCEDURE WAS PLANNED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16948 NEXUS IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1468

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R