BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2780640 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12715
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    February 18, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    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 AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK LEAD IMPEDANCES. THE PATIENT'S PHYSICIAN IS AWARE OF THE SITUATION AND THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT SUBSEQUENT HIGH SHOCKING LEAD IMPEDANCE WAS AGAIN DETECTED VIA PATIENT HOME MONITORING SYSTEM. ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE DEVICE AGAIN DETECTED HIGH OUT OF RANGE SHOCK IMPEDANCES. A COMMANDED SHOCK WAS PERFORMED AND THE DEVICE RECORDED A CODE 1005. THE SHOCK DELIVERED WAS MONOPHASIC INSTEAD OF BIPHASIC RESULTING IN MINIMUM ENERGY BEING DELIVERED TO THE TISSUE. ALTHOUGH THE CLINICAL OBSERVATIONS SUGGEST LEAD TIP CALCIFICATION INSTEAD OF A CONDUCTOR FRACTURE DUE TO THE MINIMAL ENERGY BEING DELIVERED TO THE TISSUE, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED INTERVENTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SURGICAL INTERVENTION WAS PERFORMED HOWEVER A BOSTON SCIENTIFIC REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE IT IS UNCLEAR THE CURRENT STATUS OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R