BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3212941 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09470
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A HIGH OUT-OF-RANGE PACE IMPEDANCE GREATER THAN 2000 OHMS ON THE RIGHT VENTRICULAR (RV) CHANNEL. LOSS OF CAPTURE WAS ALSO REPORTED AND THE PATIENT WAS NOTED TO HAVE NOT FELT WELL PRIOR TO FOLLOW-UP WITH THEIR CLINIC. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE LEAD WAS TESTED AND FOUND TO BE FUNCTIONING NORMALLY. THE ISSUE WAS DETERMINED TO BE DUE TO THE PACE/SENSE PORTION OF THE RV LEAD NOT BEING INSERTED CORRECTLY INTO THE HEADER OF THE CRT-D. THE LEAD WAS REINSERTED AND ALL SUBSEQUENT DIAGNOSTIC MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312196 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 6744| 0184| E030| 4047| 4470| H219| N141