BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3921672 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11478
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE GREATER THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED TO MAKE SURE THE POCKET IS CLOSED AND TEST EACH VECTOR. FURTHER, TS RECOMMENDED DISTAL COIL TO CAN AND TO DO INDUCTION TESTING. ADDITIONAL INFORMATION RECEIVED THAT THE PROXIMAL COIL WAS GIVING THE OOR IMPEDANCE. THE HEALTHCARE PROFESSIONALS TOOK THE PROXIMAL COIL OUT OF THE EQUATION AND PROGRAMMED PATIENT WITH DISTAL COIL TO CAN. THE SHOCK IMPEDANCE WITH DISTAL COIL TO CAN WAS WITHIN RANGE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400663 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR T175| E102| 4086| 0184| E143