BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3052764 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05065
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 4, 2012
    Report Date
    March 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THE LEAD AND THIS DEVICE REMAIN 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 ROUTINE DEVICE CHANGE OUT PROCEDURE, THE IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WHEN CONNECTED TO THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). SHOCK IMPEDANCE MEASUREMENTS WITH THE PREVIOUS DEVICE WERE WITHIN RANGE. TROUBLESHOOTING REVEALED SHOCK IMPEDANCE MEASUREMENTS WERE OUT OF RANGE WITH THE PROXIMAL COIL. THE PROXIMAL COIL WAS PROGRAMMED OUT OF THE SYSTEM WHICH RESOLVED THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154901 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0185| E143| T167| 4087