BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3905407 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11852
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 27, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED TO BE OPERATING NORMALLY. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. ALL SET SCREWS WERE FOUND TO MOVE NORMALLY AND COMPLETELY IN BOTH CLOCKWISE AND COUNTER CLOCKWISE DIRECTIONS, WITH NO FUNCTIONAL IRREGULARITIES FOUND. VISUAL INSPECTION OF THE LEAD BARRELS NOTED NO IRREGULARITIES TO CONTRIBUTE TO THE FIELD ALLEGATION. THE FIELD ALLEGATION OF A SET SCREW ISSUE WAS NOT ABLE TO BE CONFIRMED. HOWEVER VISUAL INSPECTION DID REVEAL A HOLE IN THE ATRIAL SEAL PLUG. NOISE ON THE ATRIAL CHANNEL MAY HAVE BEEN DUE TO TEMPORARY BODY FLUID INFILTRATION THROUGH THE SEAL PLUG, COUPLED WITH AIR ESCAPING THE SEAL PLUG. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION YET PREVENT BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. IF AN ACCESSORY SENSING PATHWAY IS PRESENT DUE TO FLUID INTRUSION, THERE IS A POTENTIAL FOR OVERSENSING AND, THUS, INHIBITION OF PACING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OVERSENSING OF NOISE WAS SEEN ON THE RIGHT ATRIAL (RA) CHANNEL. THE NOISE WAS ABLE TO BE REPRODUCED. FURTHER EVALUATION NOTED AN ISSUE WITH THE RA SETSCREW ON THE DEVICE. SUBSEQUENTLY THE DEVICE WAS ATTEMPTED AND NOT IMPLANTED. THE RA LEAD WAS LEFT IMPLANTED IN THE PATIENT WITH THE NEW DEVICE SINCE ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382328 INGENIO IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND V173

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4542| 4086| V173| 4087| 4549