BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2173690 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11277
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CAUSED A LATITUDE RED ALERT TO BE DECLARED DUE TO A HIGH OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENT. A FOLLOW UP VISIT TOOK PLACE ON (B)(6), 2011. THE IMPEDANCES WERE REVIEWED, AND THE PHYSICIAN EVALUATION WAS THAT THE SYSTEM AND THE THERAPY PROVIDED ARE WITHIN NORMAL LIMITS. THE DEVICE AND LEAD REMAIN IMPLANTED WITH NO PROGRAMMING CHANGES. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other