BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3041110 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01924
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF DEVICE MEMORY NOTED THE DEVICE HAD RECORDED ONE OR TWO FAULTS THAT WERE MOST LIKELY CAUSED BY THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143306 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4135| 6949| E163| 0184| T135| E141