BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 4150873 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17127
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AFTER THE POCKET WAS CLOSED, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED NOISE ON THE RV RATE SENSE CHANNEL. PACING INHIBITION GREATER THAN TWO SECONDS OF ASYSTOLE WAS NOTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE DEVICE WAS LEFT OFF FOR AN HOUR. HOWEVER, THE DEVICE WAS TURNED ON AND THERE WAS NO OVERSENSING OBSERVED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633577 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0292| 4543| S606| 4469| N140| 4470