BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3210314 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08253
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCES FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WERE DETECTED. DEVICE EVALUATION WAS PERFORMED AND IT WAS NOTED THAT OVER THE LAST MONTH THE RIGHT ATRIAL (RA), LEFT VENTRICULAR (LV), AND RV PACING IMPEDANCES HAVE ALL RISEN AT THE SAME RATE, BUT NO OUT OF RANGE MEASUREMENTS WERE REPORTED. IT WAS REPORTED THAT THE HIGH VOLTAGE SHOCK LEAD IMPEDANCE WAS STABLE IN THE 60S THEN A READING> 200 OHMS WAS OBTAINED, AND SINCE THE READINGS HAD BEE NORMAL. THE INFORMATION WAS DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). THE FIELD REPRESENTATIVE REVIEWED THAT THE RV COIL TO RA COIL IMPEDANCE WAS 90 OHMS, THE RV COIL TO CAN WAS 145 OHMS, AND IN TRIAD THE MEASUREMENT WAS 70 OHMS. THE PATIENT HAD RECEIVED A SHOCK LATE LAST YEAR AND THE LEAD IMPEDANCE WAS 43 OHMS. TS SUGGESTED CONSIDERATION OF A 1.1 JOULE AND MAXIMUM ENERGY SHOCK TO TEST THE INTEGRITY OF THE SYSTEM. HOWEVER, IT WOULD BE UP TO THE PHYSICIAN AS IT WAS REPORTED THE PATIENT WAS HAVING ISSUES WITH HEART FAILURE. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE. NO LAB TESTING OR DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. AT THIS TIME, THE PLAN WAS TO CONTINUE TO CLOSE MONITOR THROUGH THE PATIENT'S REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310382 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 1860| 0157| MISMATCH| E102| 4469| N161