BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3761265 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08200
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 30, 2014
    Report Date
    May 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT A RECURRENT ALERT WAS DETECTED FOR THIS ICD AND RV LEAD SYSTEM AS IT EXHIBITED CONTINUED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS CHECKED IN THE CLINIC AND THE IMPEDANCE MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS DETECTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM AS IT EXHIBITED ZERO OHM SHOCK IMPEDANCE MEASUREMENT. THERE WAS NOISE NOTED ON THE SHOCK VECTOR. THE HEALTH CARE PROFESSIONAL (HCP) BELIEVED THAT ELECTROMAGNETIC INTERFERENCE (EMI) HAD CAUSED THE ZERO OHM IMPEDANCE MEASUREMENT AND WILL CONTINUE TO MONITOR THE PATIENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED PERFORMING ISOMETRICS AND COMMANDED SHOCKS TO TEST THE INTEGRITY OF THE SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE OUT OF RANGE IMPEDANCE MEASUREMENT WAS NOT DETERMINED. THE DEVICE AND RV LEAD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240977 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 0296| E140