BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2936191 · Received January 30, 2013

    Report

    Report Number
    2124215-2013-02016
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING A REVISION PROCEDURE WAS PERFORMED TO ADDRESS THE ISSUES WITH THIS LEAD. THE CALLER HAD AN ADDITIONAL INQUIRY REGARDING THE PATIENT. IT WAS NOTED THAT THIS PATIENT HAS A SILENT ATRIUM, THE DEVICE WAS PROGRAMMED TO 60PPM, AND DURING THE REVISION PROCEDURE, WITH NO RIGHT VENTRICULAR (RV) LEAD INSERTED INTO THE DEVICE THERE WAS NO PACING OBSERVED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT EXPLAINED TO THE CALLER THAT OVERSENSING COULD OCCUR AND EVALUATION OF THE SHOCK PORTION OF THIS LEAD SHOULD BE CONFIRMED. HIGH VOLTAGE IMPEDANCE TESTING WAS PERFORMED IN VARIOUS CONFIGURATIONS AND IT WAS NORMAL EACH TIME. THEREFORE, THE DEFIBRILLATION PORTION OF THIS LEAD REMAINS IN SERVICE AND A NEW RATE SENSE LEAD WAS IMPLANTED. IT WAS NOTED THAT THE DECREASED IMPEDANCE MEASUREMENTS BEGAN TWO WEEKS AFTER AN ELECTIVE DEVICE REPLACEMENT PROCEDURE AND THE LEAD MAY HAVE BEEN COMPROMISED AT THAT TIME. BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LATITUDE HAD DETECTED A RED ALERT FOR THIS SYSTEM DUE TO LOW PACING IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE RED ALERT WITH THE CALLER. ADDITIONALLY, IT WAS NOTED THAT THE SHOCK CHANNEL LOOKED ODD, AS IF THE HIGH VOLTAGE CONNECTIONS WERE REVERSED AS AP ARTIFACT IS VERY LARGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41593 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization T125| 4470| E143| 0185