BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3212980 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09719
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. IN CONCLUSION, NO ANOMALIES WERE NOTED DURING ANALYSIS AND THE FIELD OBSERVATIONS COULD NOT BE CONFIRMED DURING TESTING.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED AND A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED ABOUT THE DEVICE BEHAVIOR. THE AGENT REVIEWED THE CASE AND ADVISED THAT DUE TO THE NATURE OF THE SUB-THRESHOLD IMPEDANCE TESTING, THE MEASUREMENTS CAN BE AFFECTED BY ELECTROMAGNETIC INTERFERENCE (EMI) FROM OR EQUIPMENT. OR IF EXTERNAL DEVICES ARE CONNECTED TO THE PATIENT (E.G.: EXTERNAL ECK MONITOR), THIS MAY INFLUENCE THE IMPEDANCE MEASUREMENTS (ESPECIALLY THE SHOCK LEAD IMPEDANCE). IF THIS OCCURS AGAIN DURING ANOTHER IMPLANT, TRY REPEATING THE MEASUREMENTS AFTER ALL EXTERNAL EQUIPMENT IS DISCONNECTED FROM THE PATIENT. THE FACT THAT THE IMPEDANCE MEASUREMENTS ARE STABLE AND WITHIN RANGE WHEN THE MEASUREMENTS ARE PERFORMED OUTSIDE THE OR (NORMALLY NO EXTERNAL EQUIPMENT CONNECTED TO THE PATIENT) IS CONSISTENT WITH THIS BEHAVIOUR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CONNECTED TO THE NEWLY RIGHT VENTRICULAR (RV) LEAD IMPLANTED LEAD. THE DEVICE WAS INTERROGATED AND REVEALED NORMAL MEASUREMENTS EXCEPT FOR SHOCKING IMPEDANCES RELATED TO THE CAN AS SHOCK IMPEDANCES WERE LESS THAN 20 OHMS. THE PHYSICIAN PRESSED DOWN ON THE POCKET AND SHOCK IMPEDANCE MEASUREMENTS REMAINED LOW. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED AND ADVISED THAT THEY HAVE SEEN THIS TYPE OF DEVICE BEHAVIOR WITH SMALLER PATIENTS. DUE TO THE PATIENT'S LOW BLOOD PRESSURE AND PRE-EXISTING LUNG DISEASE THE PHYSICIAN ELECTED TO REMOVE AND REPLACE THE DEVICE TO COMPLETE THE PROCEDURE. THE NEW DEVICE WAS TESTED AND REVEALED THE SAME MEASUREMENTS. THE PHYSICIAN ACCEPTED THE MEASUREMENTS AND THE POCKET WAS CLOSED. THE PATIENT WAS FOLLOWED UP THE NEXT DAY AND ALL MEASUREMENTS REMAINED NORMAL AND WITH IN RANGE. THE DEVICE WAS RETURNED FOR ANALYSIS WHILE THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314070 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F140

    Patients

    Seq Age Sex Outcome Treatment
    1