BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 2911427 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16562
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 2, 2012
    Report Date
    June 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED. INITIAL ANALYSIS WAS PERFORMED AND FOUND THE DEVICE TO MEET SPECIFICATIONS. A REQUEST FOR ADDITIONAL ANALYSIS TO BE PERFORMED HAS SENT. THIS REPORT WILL BE UPDATED ONCE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

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    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 PASSED AUTOMATED RP2 TESTS, PIN GAGE TESTS, AND THE LEAD SEAL WITNESS MARKS INDICATE THAT ALL LEADS WERE FULLY INSERTED. 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 FOLLOWING THE IMPLANT OF THIS DEVICE, OUT OF RANGE PACING IMPEDANCES WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THIS DEVICE WAS EXPLANTED ONE MOTH POST IMPLANT AS AN ELECTIVE PROCEDURE TO BE COMPATIBLE WITH THE DF4 LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17574 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R T175| 0185| E161