BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2910771 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16433
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 19, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF EVIDENCE SUBMITTED BY THE FIELD INDICATED THAT THE NOISE ON THE VENTRICULAR CHANNEL WAS CONSISTENT WITH TEMPORARY BODY FLUID INFILTRATION THROUGH THE SEAL PLUG, COUPLED WITH AIR ESCAPING THE SEAL PLUG. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION YET PREVENT BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. IF AN ACCESSORY SENSING PATHWAY IS PRESENT DUE TO FLUID INTRUSION, THERE IS A POTENTIAL FOR OVERSENSING AND, THUS, INHIBITION OF PACING OR DELIVERY OF INAPPROPRIATE THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE ON THE RATE/SENSE CHANNEL WHICH WAS OVERSENSED AND RESULTED IN INAPPROPRIATE DELIVERY OF ANTI-TACHYCARDIA PACING (ATP). THE NOISE OCCURRED A COUPLE HOURS POST IMPLANT AND ONLY ONE EPISODE WAS STORED. ALL DIAGNOSTICS WERE ACCEPTABLE AT THE POST OPERATIVE DEVICE CHECK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16560 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 0282| E140