BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3210193 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06914
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    March 24, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHOCKING IMPEDANCES REMAINED STABLE BUT OUT OF RANGE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT INDUCTION TESTING WAS PERFORMED AND IT WAS NOTED THAT THE SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. NO FURTHER CHANGES WERE MADE AND THE SYSTEM REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT THE SHOCK IMPEDANCE TESTING WAS PERFORMED WITH A 1.1 J SHOCK WHICH REPORTED A NORMAL SHOCK IMPEDANCE VALUES WHILE A 41 J SHOCK SHOWED A VALUE CLOSE TO BEING OUT OF RANGE. ALSO A LOW ENERGY SHOCK WAS PERFORMED WHICH SHOWED OUT OF RANGE SHOCK IMPEDANCE VALUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR NEXT STEPS. A REVIEW BY TS NOTED THAT THERE WAS SUSPECTED CALCIFICATION AROUND THE LEAD TIP AND/OR COIL THAT COULD CAUSE OBSERVED ELEVATION IN RV PACING THRESHOLDS AS WELL AS HIGH SHOCK IMPEDANCE MEASUREMENTS WITH HIGH ENERGY TESTING. TS NOTED THAT THIS IS AN ACTIVE FIXING SINGLE COIL LEAD WITH TEN YEARS OF IMPLANT, NO NOISE ON EGM OBSERVED DURING PROVOCATIVE MANEUVERS AND POCKET MANIPULATION, AS WELL AS NO NOISE OBSERVED IN STORED EGG. SHOCK IMPEDANCE MEASUREMENTS AND RV PACING THRESHOLD WERE SLOWLY GROWING OVERTIME IN THE LAST YEARS AND RV IMPEDANCE TREND WAS CONSTANT. TS DISCUSSED NORMAL FOLLOW UPS AND TO VERIFY NO MECHANISM NOISE WAS PRESENT OR A SUSPECTED MECHANICAL ISSUE. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANG SHOCK IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311301 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F161

    Patients

    Seq Age Sex Outcome Treatment
    1