BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN ICD

    MDR report key: 11227785 · Received January 25, 2021

    Report

    Report Number
    2124215-2020-29012
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    May 2, 2020
    Report Date
    May 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526480744
    PMA / PMN Number
    P960040/S235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THERE WAS NO CONCLUSIVE EVIDENCE THAT THE OBSERVED OUT-OF-RANGE IMPEDANCE MEASUREMENTS WERE DUE TO A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION. HOWEVER, INTERMITTENT, OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION ARE LIKELY THE RESULT OF THE LOW-ENERGY TEST SIGNAL UTILIZED FOR DAILY AUTOMATIC OR IN-CLINIC COMMANDED SHOCK LEAD IMPEDANCE TESTING. A SOFTWARE UPDATE WAS RELEASED IN 2015 TO FURTHER IMPROVE CONSISTENCY OF THE IMPEDANCE TEST RESULTS AND PROVIDE THE CLINICIAN WITH ADDITIONAL DIAGNOSTIC TOOLS, INCLUDING PROGRAMMABLE SHOCK LEAD IMPEDANCE ALERT LIMITS. -- THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAGE 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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THERE WAS NO CONCLUSIVE EVIDENCE THAT THE OBSERVED OUT-OF-RANGE IMPEDANCE MEASUREMENTS WERE DUE TO A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION. HOWEVER, INTERMITTENT, OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION ARE LIKELY THE RESULT OF THE LOW-ENERGY TEST SIGNAL UTILIZED FOR DAILY AUTOMATIC OR IN-CLINIC COMMANDED SHOCK LEAD IMPEDANCE TESTING. A SOFTWARE UPDATE WAS RELEASED IN 2015 TO FURTHER IMPROVE CONSISTENCY OF THE IMPEDANCE TEST RESULTS AND PROVIDE THE CLINICIAN WITH ADDITIONAL DIAGNOSTIC TOOLS, INCLUDING PROGRAMMABLE SHOCK LEAD IMPEDANCE ALERT LIMITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS NOTED THAT THE DEVICE HAD NOT DELIVERED SHOCKS SINCE IMPLANT (2013).TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES INCLUDING CALCIFICATION. TS ALSO DISCUSSED INCREASING THE ALERT LIMIT AND CONSIDERING COMMANDED SHOCKS. THIS DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. HOWEVER THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. IT WAS NOTED THAT SHOCK IMPEDANCE MEASUREMENT AT THE UPGRADE PROCEDURE WAS 42 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THERE WAS NO CONCLUSIVE EVIDENCE THAT THE OBSERVED OUT-OF-RANGE IMPEDANCE MEASUREMENTS WERE DUE TO A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION. HOWEVER, INTERMITTENT, OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR AN INADEQUATE LEAD-TO-DEVICE CONNECTION ARE LIKELY THE RESULT OF THE LOW-ENERGY TEST SIGNAL UTILIZED FOR DAILY AUTOMATIC OR IN-CLINIC COMMANDED SHOCK LEAD IMPEDANCE TESTING. A SOFTWARE UPDATE WAS RELEASED IN 2015 TO FURTHER IMPROVE CONSISTENCY OF THE IMPEDANCE TEST RESULTS AND PROVIDE THE CLINICIAN WITH ADDITIONAL DIAGNOSTIC TOOLS, INCLUDING PROGRAMMABLE SHOCK LEAD IMPEDANCE ALERT LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS NOTED THAT THE DEVICE HAD NOT DELIVERED SHOCKS SINCE IMPLANT (2013).TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES INCLUDING CALCIFICATION. TS ALSO DISCUSSED INCREASING THE ALERT LIMIT AND CONSIDERING COMMANDED SHOCKS. THIS DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121316 ENERGEN ICD IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E143 108005 00802526480744

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male