BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2780134 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12816
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. BOTH DISTAL SETSCREWS WERE IN THE UP POSITION AND MOVED FREELY. THE SPRING ELECTRODES WERE MEASURED AND WERE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE MEMORY NOTED NO FAULTS HAD OCCURRED AND NO STORED EPISODES WERE FOUND. THE PACING AND SENSING FOR RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE UNIPOLAR AND THE LEAD SAFETY SWITCH HAD OCCURRED THE DAY AFTER THE ATTEMPTED IMPLANT (WHICH WOULD SUGGEST THE DEVICE WAS IN BIPOLAR MODE DURING IMPLANT TESTING). 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER IMPLANT TESTING OF LEADS THROUGH THE PACING SYSTEM ANALYZER (PSA), THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED INTO THE (B)(4) HEADER. UPON REVIEW OF THE SURFACE EKG P-WAVES WERE OBSERVED AT A RATE OF 70 BPM, HOWEVER NO R-WAVES WERE OBSERVED. THE PATIENT HAD REMAINED IN COMPLETE HEART BLOCK. MULTIPLE ATTEMPTS WERE MADE TO RE-CONNECT THE DEVICE TO THE LEAD WITH SAME RESULTS. A LEAD TO DEVICE CONNECTION ISSUE WAS SUSPECTED. THIS DEVICE WAS REMOVED AND A NEW (B)(4) DEVICE WAS ATTEMPTED. THIS DEVICE ALSO EXHIBITED NO PACING WHEN THE RV LEAD WAS INSERTED INTO THE DEVICE HEADER AND THE SET SCREWS WERE TIGHTENED. A COMPETITOR DEVICE WAS THEN UTILIZED AND UPON INSERTING THE RV LEAD INTO THE COMPETITOR DEVICE HEADER, NORMAL PACING WAS OBSERVED. OVERSENSING WAS SUSPECTED ON THE PREVIOUS TWO DEVICES, HOWEVER THERE WERE NO STRIPS RUN OR PRINTED AND THE DEVICE'S WERE NOT TESTED IN VOO MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4135| 4136| K063| VEDR01