BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3771435 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09128
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    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 UPON INTERROGATION A CHECK LEAD MESSAGE APPEARED. FURTHER REVIEW FOUND THAT THE DEFIBRILLATOR AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED TWO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. REVIEW OF OTHER LEAD MEASUREMENTS FOUND APPROPRIATE THRESHOLD MEASUREMENTS, NO NOISE AND FLUCTUATING PACING IMPEDANCE MEASUREMENTS FROM 796 TO 1116 OHMS WITH NO SPIKES. ISOMETRICS DID NOT PRODUCE ANY NOISE OR OUT OF RANGE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED TROUBLESHOOTING OPTIONS. NO FURTHER INFORMATION WAS AVAILABLE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249231 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR E140| 0282