BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 4131700 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17629
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDSATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) AND NOISE BEING OVERSENSED RESULTED TO ASYSTOLE GREATER THAN 2 SECONDS. THE HEALTH CARE PROFESSIONAL (HCP) NOTED NOISE IN NON-SUSTAINED EPISODES ON RIGHT VENTRICULAR (RV) WHICH RESULTED TO ASYSTOLE GREATER THAN TWO SECONDS. RV LEAD MEASUREMENTS LOOKED STABLE. FURTHER, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED PRESENTING ELECTROGRAM (EGM) AND CONFIRMED LOC BASED ON LACK OF DEFLECTIONS ON LEFT VENTRICULAR (LV) EGM AND ISOLATED NOISE IN 2 MOST RECENT SUSTAINED EPISODES. TS DISCUSSED THAT THE 2 MOST RECENT ATR¿S THAT WERE CAPTURED AT THE END OF AN LV THRESHOLD TEST. FURTHERMORE, THE PATIENT WAS BROUGHT INTO CLINIC AND THE PHYSICIAN PROGRAMMED THRESHOLD TO 0.9V AT 2MS. TS DISCUSSED TROUBLESHOOTING MEASURES. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE WAS NOT DETERMINED AND THEY SELECTED NEW LV PACING VECTOR. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613154 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0174| 4543| N119| 4469