BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212595 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09744
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    October 21, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP, THIS DEVICE DATA REVEALED TWO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SIX INAPPROPRIATE SHOCKS WERE DELIVERED THAT EXHAUSTED THERAPY. THE HEART RATE HAD ACCELERATED DURING EXERCISE, DETECTED IN THE VT-1 ZONE AND ACCELERATED TO THE VT ZONE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE REASON FOR THIS INAPPROPRIATE THERAPY. IT WAS DETERMINED THAT THE EPISODE STARTED AS A VT-1. ACCORDING TO THE DEVICE SETTINGS, THE VT-1 ZONE IS PROGRAMMED TO A MONITOR ONLY ZONE SO WHEN DETECTION AND DURATION WERE MET, THE DEVICE IMMEDIATELY GO TO REDETECTION AND REDETECTION DURATION. DURING REDETECTION, DETECTION ENHANCEMENTS ARE NO APPLIED. WHEN THE RATE ACCELERATED, THE DEVICE STILL WAS IN REDETECTION MEANING THAT ONCE THE VT CRITERIA ARE MET, THE DEVICE MOVED FORWARD TO THERAPY AND THE SCENARIO REPEATED UNTIL THERAPY IS EXHAUSTED. THIS MAY HAVE BEEN DUE TO THE SOFTWARE UPDATE FOR THIS DEVICE PERFORMED AFTER THIS EPISODE AND THE DEVICE MAY HAVE OPERATED AS PROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT AN X-RAY TOOK PLACE WHICH DID NOT SHOW A LEAD FRACTURE, THE DEVICE WAS REPROGRAMMED AND THE PATIENT IS BEING CONSIDERED FOR A POSSIBLE ABLATION IF THE EVENT RECURS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THIS PATIENT RECEIVED SHOCK DUE TO VENTRICULAR FIBRILLATION AND A FAULT CODE 1005 WAS NOTED, WHICH INDICATED AN OPEN CONDITION PRESENT DURING SHOCK DELIVERY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLY REPLACING THE SYSTEM AS WELL AS EVALUATION THE SYSTEM. TS ALSO NOTED SHOCKS INITIALLY TERMINATE THE ARRHYTHMIA BUT AFTER SEVERAL SECONDS, THE FAST RHYTHM RETURN, ALSO THE SHOCK IMPEDANCE TREND SHOWS A HIGH VALUE (>125 OHMS) FOR QUITE SOME TIME AND THEN THE LAST VALUE DROPPED SIGNIFICANTLY INTO THE 80 OHM RANGE, THIS PHENOMENON COULD NOT BE EXPLAINED. A SAVE TO DISK IS PENDING FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BY ENGINEERING EVALUATION NOTED THAT SEVERAL SHOCKS WERE DELIVERED BY THE DEVICE AND THE REVIEWED EPISODE ENDED WITH THERAPY EXHAUSTION. THE DAILY LEAD IMPEDANCE MEASUREMENTS SHOW SHOCK IMPEDANCES STEADILY INCREASING FROM ABOUT 100 TO 144 AND THEN SUDDENLY DROPPED TO 84 OHMS FOR THE LAST MEASUREMENT. ENGINEERING NOTED THAT ACCORDING TO THE FAULTS AND ACTIONS GUIDE THEY SHOULD CONSIDER EVALUATING THE DEVICE AND LEAD SYSTEM INTEGRITY TESTING. ENGINEERING NOTED THAT ALTHOUGH THE DEVICE DOES NOT APPEAR TO HAVE SUFFERED ANY ILL-EFFECTS FROM THE FAULT CODE FURTHER EVALUATION IS NEEDED. NO FURTHER ACTION WAS TAKEN AND THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN ELECTRICAL STORM OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA. A ERROR CODE 1005 OCCURRED AND THE SHOCK IMPEDANCE MEASUREMENTS WERE HIGH AND OUT OF RANGE. ALL THE SHOCKS WERE SUCCESSFUL. AN INQUIRY WAS SENT FOR TECHNICAL REVIEW. THE PATIENT REMAINS HOSPITALIZED. A REVIEW OF THE DISK DATA BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT CODE 1005 IS TRIGGERED WHEN THE DEVICE DELIVERS A SHOCK INTO AN IMPEDANCE THAT IS TOO HIGH.TS ALSO NOTED THAT AFTER THE HIGH VOLTAGE FAULT IS TRIGGERED THE LOGBOOK WILL INCORRECTLY LIST THE THERAPY DELIVERED IN THE LOGBOOK BUT THE EPISODE DETAILS WILL BE CORRECT. THIS IS WHY TWO OF THE EPISODES INDICATE NO THERAPY IN THE LOGBOOK EVEN THOUGH THEY DID ACTUALLY DELIVER A SHOCK. THE DAILY MEASUREMENTS FOR SHOCK IMPEDANCE HAVE ALSO BEEN TRENDING NEAR 140 OHMS. AFTER THE 8 SHOCKS WERE DELIVERED ON (B)(6) 2016 THE DAILY MEASUREMENTS FOR SHOCK IMPEDANCE DROPPED DOWN TO AROUND 80 OHMS BUT SINCE THEN THE SHOCK IMPEDANCE HAS GRADUALLY INCREASED BACK UP TO AROUND 140 OHMS. TS NOTED THIS IS TYPICALLY AN INDICATION OF AN OPEN CIRCUIT CONDITION AND A LEAD ISSUE WOULD BE SUSPECTED. TS NOTED THAT THIS CASE WAS UNIQUE IN THAT THE SHOCK IMPEDANCE APPEARS TO BE VERY HIGH BUT NOT A COMPLETE OPEN CIRCUIT CONDITION AS THE LIMITED ENERGY THAT IS BEING DELIVERED APPEARED TO HAVE CONVERTED THE VENTRICULAR RHYTHM. TS CONFIRMED THAT THE RECENT DELIVERED SHOCKS DO APPEAR TO CONVERT THE RHYTHM BUT SINCE THE SHOCKS ARE BEING TRUNCATED IT IS POSSIBLE THE PATIENT COULD HAVE AN ARRHYTHMIA THAT WOULD NOT BE SUCCESSFULLY CONVERTED WITH THE LIMITED ENERGY. A LEAD REPLACEMENT WAS RECOMMENDED AND A POSSIBLE DEVICE ISSUE COULD NOT BE RULED OUT. IT WAS NOTED THAT THIS IS THE SECOND TIME THE DEVICE DISPLAYED CODE 1005 WHICH OCCURRED (B)(6) 2016, BUT NO INFORMATION WAS RECEIVED REGARDING ANY FURTHER ACTIONS AND NO TEST SHOCKS OR REVISION HAD TAKEN PLACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A REPLACEMENT OF THIS RV LEAD DUE TO A FRACTURE. NO FURTHER INFORMATION WAS PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313997 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1