BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3052812 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04187
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    May 17, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED STATING THE SHOCKING IMPEDANCE MEASUREMENTS WERE STILL OUT OF RANGE TWO YEARS AFTER THE INITIAL OBSERVATIONS WERE REPORTED. ALL OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS. THE PATIENT'S PHYSICIAN IS AWARE OF THE HIGH IMPEDANCES. A BOSTON SCIENTIFIC SALES REPRESENTATIVE HAD NO KNOWLEDGE THAT ADDITIONAL PATIENT TESTING HAD OCCURRED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS SYSTEM HAS BEEN EXHIBITING ELEVATED PACING IMPEDANCE MEASUREMENTS WHICH ARE NOW AT 1500 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND OPTIONS FOR THIS PATIENT. THE PATIENT WILL CONTINUE TO BE MONITORED. 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

    A REVISION PROCEDURE WAS PERFORMED AND THE ASSOCIATED RV LEAD WAS REMOVED FROM SERVICE AND REPLACED DUE TO THE CONTINUED HIGH AND OUT OF RANGE SHOCKING AND PACING IMPEDANCE MEASUREMENTS. THIS DEVICE REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS WAS NOT DETERMINED. 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

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED MONITORING THE IMPEDANCE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PROCEDURE TO IMPLANT THIS DEVICE, SHOCKING IMPEDANCE MEASUREMENTS WERE 100-125 OHMS AND MOST MEASUREMENTS WERE GREATER THAN 125 OHMS. THERE WAS NO NOISE OBSERVED AND ALL OTHER LEAD DIAGNOSTICS WERE NORMAL. THE ASSOCIATED LEAD WAS RE-INSERTED BACK INTO THE OLD DEVICE AND MEASUREMENTS WERE 70-80 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT SUGGESTED SOME TROUBLESHOOTING WHICH THE CALLER PERFORMED WITH NO CHANGES TO THE MEASUREMENTS. THE CALLER STATED THAT MEASUREMENTS DECREASED AND WERE BETWEEN 73 -91 OHMS. THE DEVICE WAS IMPLANTED AND NO ADVERSE PATIENT EFFECT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155658 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R T125| 4470| E143