BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3212891 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09584
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 15, 2013
    Report Date
    October 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDER GO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, 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 DURING AN IMPLANT PROCEDURE, THIS DEVICE WAS CONNECTED TO THE IMPLANTED LEAD AND THE SCREWS WERE TIGHTENED. THE PHYSICIAN PULLED ON THE LEAD TO TEST THE CONNECTION OF THE DEVICE AND LEAD. UPON PULLING THE LEAD IT BECAME LOOSENED AND SEPARATED FROM THE DEVICE. THE CONNECTION COULD NOT BE TIGHTLY SECURED. MULTIPLE ATTEMPTS WERE MADE TO RECONNECTED THE DEVICE AND LEAD, HOWEVER THE SAME LOOSE CONNECTION WAS FOUND. THE DECISION WAS MADE TO IMPLANT A NEW DEVICE, WHILE THE LEAD REMAINS IMPLANTED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312617 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 0484

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR