BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3211672 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07726
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM HAS ISSUED ALERTS FOR INTERMITTENT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOLLOWING THESE ALERTS. REVIEW OF THE REMOTE HOME MONITORING DATA REVEALED INTERMITTENT OVERSENSING OF NOISE LEADING TO INAPPROPRIATE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. NO PACING INHIBITION WAS OBSERVED AS THE PATIENT HAS AN UNDERLYING RHYTHM. TS DISCUSSED BRINGING THE PATIENT IN FOR EVALUATION. THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT FOR A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS TRIGGERED VIA THE REMOTE HOME MONITORING SYSTEM. THE PHYSICIAN OPTED TO MONITOR THE PATIENT VIA THE REMOTE HOME MONITORING SYSTEM AS HER EJECTION FRACTION IS 55 PERCENT. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308920 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 0184| 4518| N141| 4592| 4470