BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3771535 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-08186
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    January 13, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    TECHNICAL ASSISTANCE WAS REQUESTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE PROVIDED DISK AND NOTED HISTORICALLY UNSTABLE SHOCK IMPEDANCE MEASUREMENTS. THERE WERE ALSO FIVE PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODES. AS THERE WERE VERY FLUCTUATING SHOCK IMPEDANCES, ADDITIONAL INVESTIGATION WAS ADVISED. IT WAS REPORTED THAT THE PATIENT WILL BE CHECKED AT THEIR NEXT SCHEDULED FOLLOW UP.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS OBSERVED ON THE IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND AN UNKNOWN RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. IT WAS REPORTED THAT ALL OTHER MEASUREMENTS WERE WITHIN RANGE SO THE PHYSICIAN DECIDED TO TURN OFF THE ALARM. TECHNICAL ASSISTANCE WAS REQUESTED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE RV LEAD WAS A BSC PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249366 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 P108