BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3951207 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14269
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 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 RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. AT THIS TIME, THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427845 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0292| E140