BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3904494 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08930
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. 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 DURING A DEVICE UPGRADE PROCEDURE, WHEN THIS RIGHT VENTRICULAR LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. THE CONNECTION WAS VERIFIED AND IT WAS CONFIRMED THE DEVICE WAS IN THE POCKET. ALL SHOCK VECTORS HAD BEEN TESTED. TS SUGGESTED DISCONNECTING AND RECONNECTING THE LEADS. IN ADDITION, IT WAS RECOMMENDED TO ENSURE THE POCKET IS WELL IRRIGATED AND NOT DRY. FURTHER TESTING REVEALED COIL TO COIL CONFIGURATION IS OUT OF RANGE; HOWEVER RV TO CAN CONFIGURATION REVEALED NORMAL MEASUREMENTS. THERE WAS CONCERN THAT THERE MAY BE A PROXIMAL COIL INTEGRITY ISSUE. IT WAS CONFIRMED THERE WERE NO ISSUES RELATED TO LEAD TERMINAL PIN INSERTION, AND THERE WAS NO EVIDENCE OF PHYSICAL DAMAGE OR A COMPROMISED TERMINAL LEG. TS FURTHER RECOMMENDED PURSUING SINGLE COIL OF RV TO CAN. A FURTHER ATTEMPT TO DISCONNECT AND RECONNECT THE LEADS WAS PERFORMED. IN ADDITION, THE PORT WAS FLUSHED AND THE TERMINAL PIN WAS CLEANED. MEASUREMENTS WERE TILL OUT OF RANGE. A DECISION WAS MADE TO LEAVE THE LEAD PROGRAMMED TO SINGLE COIL IN RV TO CAN CONFIGURATION AND LEAVE THE SYSTEM IMPLANTED. AN XRAY WAS PERFORMED REVEALING A SIGNIFICANT LEAD BEND AT THE LOCATION OF THE PROXIMAL COIL. IT WAS THOUGHT THIS MAY HAVE CONTRIBUTED TO THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384912 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 T165| E143| 0165| 4574