BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3213722 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10368
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE (SLI) MEASUREMENTS OF GREATER THAN 200 OHMS. THE PATIENT WAS REPORTED HAVING DIFFICULTY OF BREATHING BUT THOUGHT OF NOT RELATED TO THE DEVICE. THE FIELD REPRESENTATIVE THOUGHT THAT THE PROXIMAL TERMINAL PIN MAY HAVE MOVED. THE PHYSICIAN DECIDED TO PROGRAM DISTAL COIL TO CAN EVEN IF IT WAS NOT TESTED. THERE WAS NO NOISE REPORTED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312387 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 0184| E143| 4473| T165