BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3213067 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10501
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WITH THIS DEVICE RECEIVED SIX INAPPROPRIATE SHOCKS AT HOME THAT LED TO THERAPY EXHAUSTION. DURING A FOLLOW UP VISIT, THE DEVICE WAS REPROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE PRINT OUTS PROVIDED FOR THE EPISODE ON (B)(6) 2013. AN EPISODE WAS DETECTED IN THE VT ZONE. THE DETECTION ENHANCEMENT ALGORITHM RHYTHM ID (RID) WAS ON FOR INITIAL DETECTION AND NOT FOR POST-SHOCK DETECTION. AT THE END OF THE DURATION PERIOD, NO TACHY THERAPY WAS DELIVERED AS THE RID WAS CORRELATED. FOR AN UNKNOWN REASON, THE MORPHOLOGY OF THE QRS COMPLEXES CHANGED (EVEN IF NOT VISIBLE ON THE SHOCK CHANNEL) AND THE PERCENTAGE OF CORRELATION BECAME LESS THAN 94%. BECAUSE OF THAT , RID BECAME UNCORRELATED AND TACHY THERAPIES WERE DELIVERED. NONE OF THE TACHY THERAPIES (SIX ANTITACHYCARDIA PACING, 11J, 23J, AND 4- 41JOULE SHOCKS) STOPPED THE ONGOING FAST RHYTHM. THE FAST VENTRICULAR RHYTHM DID NOT SLOW DOWN OR DID NOT DEGENERATE INTO VT OR VF WITH THE TACHY THERAPY DELIVERIES. IT APPEARS THAT THE TACHY THERAPIES HAVE BEEN DELIVERED DURING A SINUS TACHYCARDIA EPISODE. TS CONCLUDED THAT FROM A CLINICAL POINT OF VIEW, THE TACHY THERAPIES SEEM TO BE INAPPROPRIATE. HOWEVER, FROM A TECHNICAL ANALYSIS, THE DEVICE WORKED AS DESIGNED AND PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311940 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1