BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 4140094 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16969
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENT REMAINS UNKNOWN. THE IMPEDANCES HAVE APPARENTLY DROPPED BACK TO WITHIN RANGE AND NO CHANGES HAVE BEEN MADE TO THE SYSTEM. AT THIS TIME THE PATIENT¿S RV LEAD AND ICD CONTINUE TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620386 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 E140