BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3212996 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09282
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT FOR HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS WAS DETECTED VIA REMOTE MONITORING. THE HEALTH CARE FACILITY WAS ALERTED AND DISMISSED THE ALERT.ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN IN THE CLINIC AND THEY DO NOT BELIEVE THERE IS ANY PERFORMANCE ISSUE WITH THE LEAD. THE LEAD WILL CONTINUE TO BE MONITORED REMOTELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313351 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 0293| E140