BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3981159 · Received August 5, 2014

    Report

    Report Number
    2124215-2014-14995
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P010012/S165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    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 NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL OF THIS SYSTEM WHICH RESULTED IN INAPPROPRIATE THERAPY FOR THIS PATIENT. ADDITIONALLY, A LATITUDE RED ALERT WAS GENERATED DUE TO PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE PHYSICIAN DISCUSSED ALL THE OPTIONS WITH THE PATIENT AND THE PATIENT DECIDED NOT TO HAVE ANOTHER SURGICAL PROCEDURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PORTION OF THE DEVICE WAS THEN TURNED OFF AND THE CARDIAC RESYNCHRONIZATION THERAPY REMAINED INTACT. THE RV LEAD WAS ABANDONED ELECTRICALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF CAPTURE, NOISE AND PACING INHIBITION WERE OBSERVED VIA A TELEMETRY STRIP. THERE WERE NO EPISODES OF NOISE IN THE LOGBOOK; HOWEVER, IT COULD BE LOW LEVEL MYOPOTENTIALS BEING PICKED UP WHICH MAY NOT TRIGGER AN EVENT BUT WOULD STILL INHIBIT A PACED BEAT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED HAVING THE PATIENT PERFORM ISOMETRICS TO FURTHER EVALUATE THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458278 COGNIS IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION N119 195177

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR 0154| T165| 1226| 4269| 1851| 4261| 4592| N119