BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2041835 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01261
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    November 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT ELECTROGRAMS (EGMS) FOR THIS PATIENT WERE BEING REVIEWED AND DIAPHRAGMATIC NOISE WAS AGAIN OBSERVED ON THE RV CHANNEL. THE NOISE WAS RESULTING IN THE STORAGE OF NON SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AND THE PHYSICIAN WAS QUESTIONING THE PATIENT RATE DURING THESE EPISODES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND NOTED THE GAP THE CLINIC WAS SEEING ON THE PATIENT'S DATA FROM THEIR REMOTE MONITORING SYSTEM WAS JUST A FUNCTION OF THE REMOTE MONITORING DISPLAY AND WAS NOT A GAP IN TIME. IT WAS ALSO NOTED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING HAD BEEN DONE FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD MEASUREMENTS WERE STABLE WITH NO SIGNS OF A LEAD OR CONNECTION ISSUE. THE PHYSICIAN REVIEWED THE PATIENT'S LATITUDE INFORMATION AND NOTED THE NOISE LOOKED LIKE MYOPOTENTIAL IN NATURE. TS DISCUSSED OPTIONS OF CHANGING SENSITIVITIES IN THE RV. IT WAS ADDITIONALLY NOTED THAT DIAPHRAGMATIC OVERSENSING WAS CONFIRMED AND THE PATIENT WAS SCHEDULED FOR TESTING OF SENSITIVITY SETTINGS. THE PATIENT WAS REPORTED TO HAVE AN UNDERLYING RHYTHM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS NEWLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS A HISTORY OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL WITH THEIR PREVIOUS DEVICE, WHICH WAS OVERSENSED AND CAUSED PACING INHIBITION FOR THIS PATIENT. ADDITIONAL INFORMATION WAS PROVIDED THAT NOISE WAS AGAIN OBSERVED ON THE RV CHANNEL, WHICH WAS OVERSENSED AND AGAIN RESULTED IN PACING INHIBITION. OUT OF RANGE RV IMPEDANCES WERE ALSO NOTED; HOWEVER, IT WAS UNKNOWN WHETHER THEY WERE HIGH OR LOW. IT WAS NOTED THAT THE PATIENT WAS BROUGHT IN TO THEIR CLINIC AND ALL LEAD DIAGNOSTICS WERE NORMAL. NOISE WAS ABLE TO BE RECREATED WITH PATIENT ISOMETRICS AND VALSALVA. TS DISCUSSED TROUBLESHOOTING STEPS TO HELP FIGURE OUT IF THIS WAS A CONNECTION ISSUE OR A LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R (B)(4)| 4542| 0185| MISMATCH| H170| N119