BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043297 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02588
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, THIS EVENT WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION STATES THE PATIENT CONTINUES TO BE MONITORED AND HAS ADDITIONALLY REPORTED FEELING DIZZY AT TIMES. AN ADDITIONAL EPISODE REVIEW BY BOSTON SCIENTIFIC'S TS, CONFIRMED PERIODS OF PACING INHIBITION CAUSED BY THE SYSTEM NOISE AND LIKELY CONTRIBUTED TO THE REPORTED SYMPTOMS. TECHNICAL SERVICES REPORTED THE NOISE APPEARED TO BE MYOPOTENTIAL IN NATURE, RATHER THAN THE PREVIOUSLY SUSPECTED REVERSAL OF THE LEAD'S TERMINAL PIN WITHIN THE HEADER. SOME ADDITIONAL TROUBLESHOOTING CONTINUES.

    Description of Event or Problem · 1

    THE ADDITIONAL ELECTROGRAM REVIEW, CONCLUDED THE PATIENT WAS LIKELY ENGAGED IN SOME "EXTRA-ORDINARY" PHYSICAL ACTIVITY AT THE TIME OF THE EPISODES. THE REVIEW CONFIRMED MYOPOTENTIAL NOISE; HOWEVER, IT DID NOT RESULT IN SYSTEM OVERSENSING. ADDITIONALLY, AMPLITUDES WERE UNABLE TO BE MEASURED DUE TO BEING BELOW THE DEVICES SENSITIVITY LEVEL. THE PATIENT PERFORMED A VARIETY OF MANEUVERS FOR SYSTEM REVIEW, NONE OF WHICH RECREATED A SIMILAR NOISE PATTERN, AS THE EPISODES EARLIER OBSERVED. TO DATE NO OTHER ACTIONS REQUIRED WITH NO SYSTEM CHANGES ARE PLANNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WAS MONITORED DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) SHOCK CHANNEL. THE RV LEAD IS A COMPETITOR PRODUCT AND HAS BEEN IMPLANTED/IN SERVICE OVER TEN YEARS. ELECTROGRAM'S WERE SENT TO BOSTON SCIENTIFIC'S INTERNAL TECHNICAL SERVICES FOR ASSESSMENT, DUE TO THE POSSIBILITY OF INAPPROPRIATE THERAPY. FOLLOWING REVIEW, TS WAS UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE OF THE NOISE; HOWEVER, THERE WAS SUSPICION THAT THE HIGH VOLTAGE TERMINAL PINS MAYBE REVERSED WITHIN THE HEADER PORT OF THE DEVICE. IN THE ABSENCE OF INTERVENTION, IT WAS THE TS RECOMMENDATION, TO REPROGRAM THE DEVICE'S SHOCKING VECTOR TO DISTAL COIL-PROXIMAL COIL, ENSURING ADEQUATE SHOCK ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145453 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P106

    Patients

    Seq Age Sex Outcome Treatment
    1