BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3040839 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01547
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY RETURNED FOR TESTING. THIS PROUDUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED THAT ALL SEAL PLUGS ARE INTACT AND ALL SETSCREWS MOVE FREELY. THERE WERE NO LEAD SEAL WITNESS MARKS PRESENT IN THE HEADER. THE DEVICE WAS RECEIVED WITH THE SHOCK LEAD VECTOR PROGRAMMED TO RV COIL TO RA COIL TO CAN. MANUAL SHOCK IMPEDANCE MEASUREMENTS IN ALL THREE SHOCK CONFIGURATIONS WERE WITHIN SPECIFICATIONS. THIS DEVICE PASSED ALL RETURNED PRODUCT TESTING TESTS WHICH VERIFIED PACING, SENSING, DEFIBRILLATION, IMPEDANCE MEASUREMENT CIRCUITRY, AND RECORDING FUNCTIONS. FINAL TESTING WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S DEVICE, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS IN ALL THREE VECTORS WITH THIS REPLACEMENT DEVICE AND CHRONIC LEAD. THE CALLER CONFIRMED THERE WAS NO ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE NEAR THE POCKET DURING THE PROCEDURE. THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143445 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 0158| N141| 4470| 4543| H217