BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2780094 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12559
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    October 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE THE DEVICE AND LEAD REMAINS IMPLANTED WITH NO CHANGE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT DURING THE POST-UP CHECK, THE RIGHT ATRIAL (RA) LEAD HA WAS DISPLAYING OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. NOISE WAS ALSO OBSERVED ON THE RA CHANNEL THAT RESULTED IN ATRIAL TACHY RESPONSE (ATR) EPISODES. A CONNECTION ISSUE WAS SUSPECTED AND DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). THE PATIENT WAS GOING TO BE BROUGHT BACK IN FOR FURTHER EVALUATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS SCHEDULED FOR A LEAD CHECK TO DETERMINE ROOT CAUSE OF THE ISSUE. THERE WERE NO PATIENT SYMPTOMS AND NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR N140| 4542| 4135| 0292| 4194