BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3905363 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10763
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN AN UNSPECIFIED DURATION OF PACING INHIBITION. AN RV LEAD FRACTURE WAS SUSPECTED. SUBSEQUENTLY, WITH THE CRT-D PROGRAMMED TO OFF-ELECTROCAUTERY MODE, LOSS OF CAPTURE (LOC) RESULTING IN FIVE SECONDS OF PACING INHIBITION WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THE PATIENT WAS COMPLETELY PACEMAKER DEPENDENT. THRESHOLD MEASUREMENTS WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OFF-ELECTROCAUTERY MODE AND WAS UNABLE TO DETERMINE A POTENTIAL CAUSE FOR LV LOC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383387 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR H135| 6949| 5076| 4525| N118