BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2913143 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16647
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVIEW OF THE DAILY MEASUREMENTS DID NOT REVEAL AN OUT OF RANGE MEASUREMENT. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND WAS PROVIDED THE REASON WAS THAT THE MEASUREMENT HAD OCCURRED BEFORE THE TRENDING WINDOW HAD COMPLETED. THE INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND UNKNOWN RIGHT VENTRICULAR LEAD DISPLAYED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19646 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F142

    Patients

    Seq Age Sex Outcome Treatment
    1