BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2914325 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00965
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    March 30, 2012
    Report Date
    November 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE LOCAL FIELD REPRESENTATIVE REPORTED THAT ACCEPTABLE SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED WHEN THE PROGRAMMED CONFIGURATION WAS SET RV COIL TO CAN. ALL OTHER PROGRAMMED PARAMETERS RESULTED IN HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT ALL SETSCREWS WERE TIGHTENED AND RECHECKED AND THE PROGRAMMED CONFIGURATION WAS LEFT RV COIL TO CAN. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20476 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 0185| H217| 4470| 4543| N141