BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3223585 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09752
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 12, 2013
    Report Date
    July 11, 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING AND RECOMMENDED TESTING SYSTEM INTEGRITY. ADDITIONAL INFORMATION OBTAINED INDICATING THAT THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT FOR HIGH VOLTAGE IMPEDANCE. THE TACHY DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED THAT ANOTHER RED ALERT WAS DETECTED FOR HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT. THIS IS AN ONGOING ISSUE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS BROUGHT IN AND NO NOISE WAS OBSERVED ON THE SYSTEM. WITH THIS, NO NECESSARY ACTION WAS TAKEN ON THIS EVENT. THIS CRT-D REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT THIS PATIENT WAS CHECKED DUE TO AN ELEVATED SHOCK LEAD IMPEDANCE MEASUREMENT AND THIS DEVICE WAS OBSERVED WHICH HAS BEEN BEEPING. TRENDING SHOWED VARYING HIGH VOLTAGE SHOCK IMPEDANCE FROM 80 OHMS TO 130 OHMS. THEY ARE GOING TO MONITOR THE PATIENT FOR THE TIME BEING AND NO TESTING WAS DONE AT THIS TIME. OUR RECORDS INDICATE THE SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323526 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR MISMATCH| 4135| 0292| 4542| N140| S603| 4136