BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 7216029 · Received January 24, 2018

    Report

    Report Number
    2124215-2018-01617
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    April 1, 2014
    Report Date
    January 30, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040/S235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK IMPEDANCE ROSE TO APPROXIMATELY 108-175 OHMS, AMONG VARIOUS LEAD VECTOR CONFIGURATIONS, ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE SHOCK IMPEDANCE WAS REPORTEDLY STABLE IN (B)(6). IT WAS ALSO NOTED THAT IN (B)(6) OF 2014, THE SHOCK IMPEDANCE WAS ABOUT 93 OHMS FROM A 11 JOULE SHOCK. THE PATIENT WAS TO FOLLOW-UP WITH AN AREA ELECTROPHYSIOLOGIST AND NO FURTHER INFORMATION IS KNOWN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT HIGH SHOCK LEAD IMPEDANCES CONTINUED TO BE MEASURING ABOUT 141-177 OHMS, ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS SUBSEQUENTLY ABANDONED SURGICALLY AND REPLACED, AS A RESULT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE. THE CAUSE TO THE ISSUE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60308 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R