BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1950504 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22652
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED A SAVE TO DISK, AND CONFIRMED THERE WERE 5 INDUCTIONS THAT TOOK PLACE. TWO EPISODES WERE TREATED WITH 31 JOULE SHOCKS, WHICH SUCCESSFULLY REVERTED THE RHYTHM. ALL THE EPISODES SHOWED UNDERSENSING, WHICH WAS MOST LIKELY DUE TO RESIDUAL CHARGE ARTIFACT. THIS CAN BE SEEN POST SHOCK ON THE T WAVE, AND WILL ONLY BE SEEN IN THE CLINIC. THE ARTIFACT IS NOT OVERSENSED, HOWEVER, IT IS ADJUSTING THE AUTOMATIC GAIN CONTROL (AGC), WHICH LEADS TO UNDERSENSING. THE AGC CANNOT BECOME SENSITIVE ENOUGH IN TIME TO SEE THE NEXT INTRINSIC EVENTS WHICH ARE MUCH SMALLER THAN THE ARTIFACT. BSC TS QUESTIONED IF IT WAS POSSIBLE THAT THE SENSITIVITY WAS ADJUSTED PRIOR TO THE SAVE TO DISK. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT PROGRAMMED SENSITIVITY RANGED FROM 1.5 TO 0.7MV. BOSTON SCIENTIFIC RECOMMENDED NOMINAL 0.6MV. THE VENTRICULAR FIBRILLATION (VF) WAS A FINE VF. IN SOME CASES THE SIGNAL AMPLITUDE WAS LESS THAN 0.6MV. THE ARTIFACT OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL WAS THE RESULT OF THE ATRIAL PACE (AP), AND THE RESIDUAL ENERGY REMAINING POST SHOCK ON THE T WAVE. THE POST SHOCK ON THE T WAVE PACING DELAY WAS DIFFERENT THAN THE POST THERAPEUTIC SHOCK, AND THEREFORE THE OBSERVATION OF IMMEDIATE AP WAS ONLY APPLICABLE TO THE CLINICAL SETTING DURING INDUCTION. AS THE ARTIFACT WAS CONSIDERABLY LARGER THAN THE INTRINSIC UNDERLYING VF, THE AGC PATTERN DID NOT REACH THE VF SIGNAL RANGE BEFORE THE NEXT VP. THE VP RESET THE AGC AGAIN. IN THE STRIP THAT WAS PROVIDED, THE CYCLE CONTINUED UNTIL THERE WAS AN INTRINSIC ATRIAL SENSE, AS. THE AS DOES NOT CREATE THE CROSS-CHAMBER ARTIFACT, WHICH FOR THE VENTRICULAR SIGNALS TO BE CONTINUOUSLY SENSED. AS THE STRIP SHOWED, WHEN AP STOPPED, THE ARTIFACT STOPPED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F111

    Patients

    Seq Age Sex Outcome Treatment
    1