BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3905569 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12323
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS AND EXPLAINED PROGRAMMING OPTIONS WITH TO THE CALLER. THE CALLER STATED THAT NO CHANGES WILL BE PERFORMED NOW AND THE CLINICIAN WILL BE CONSULTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS EXPERIENCING SUPRA-VENTRICULAR TACHYCARDIA (SVT) AND RECEIVED INAPPROPRIATE DEFIBRILLATION THERAPY WHICH WAS EXHAUSTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384433 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR 4016| 4479| 0148| E143| E110| 1861