BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2936247 · Received January 30, 2013

    Report

    Report Number
    2124215-2013-02112
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 14, 2012
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. WHEN TESTING PACING IMPEDANCE MEASUREMENTS WITH THE PACING SYSTEM ANALYZER (PSA), MEASUREMENTS WERE ABOUT 1900 OHMS. THE THRESHOLD AND SENSING MEASUREMENTS WERE GOOD SO THE PHYSICIAN DECIDED NOT TO CHANGE ANYTHING. IT ALSO APPEARS THAT THE ATRIAL LEAD WAS NOT SENSING PROPERLY. THE FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO REVIEW THE ELECTROGRAM (EGM) AND DETERMINE IF THE COMPETITOR'S RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEAD TERMINAL PINS ARE REVERSE IN THE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE LEADS WERE NOT REVERSED IN THE HEADER. THE PATIENT UNDERWENT A REVISION PROCEDURE FOR A NEW COMPETITOR'S RA LEAD. THE PATIENT THEN DEVELOPED AN INFECTION AND THE ENTIRE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40316 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 4469| 1058T| 4543| H220| N119| 0174| N141