BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2910910 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16481
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 13, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ONCE ANALYSIS HAS BEEN COMPLETED THIS REPORT WILL BE UPDATED.

    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 OUT OF RANGE SHOCK IMPEDANCES GREATER THAN 125 OHMS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THIS WAS NOTED FOLLOWING THE RECENT DEVICE CHANGE OUT THAT OCCURRED IN THE PREVIOUS MONTH. THIS PATIENT HAS AN ABDOMINAL SYSTEM. THE CONCERN WAS THAT THIS MAY BE THE CAUSE OF THE OUT OF RANGE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PERFORMING FURTHER TESTING OR TO PERFORM A SAVE TO DISC FOR FURTHER INFORMATION. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT FOUR DAYS FOLLOWING THIS REPORT, THIS SYSTEM WAS PART OF A REVISION DUE TO AN INFECTION. NO ADDITIONAL TESTING OR FOLLOW-UP WAS PERFORMED BECAUSE OF THE INFECTION. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE EFFECTS RELATED TO THE OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEADS WERE ABANDONED AND REMAIN IMPLANTED. THE DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16944 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4320| E141| 0010| 6931| 6162| 0041| 1857| 1746| 1600