BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2193502 · Received August 5, 2011

    Report

    Report Number
    2124215-2011-13416
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS ACTIVELY IN SERVICE WITHOUT ALLEGATION OR EVIDENCE OF A CONNECTION ISSUE. SINCE THE RV LEAD WAS RETURNED AND ANALYSIS DETERMINED LEAD PERFORMANCE WITHIN NORMAL LIMITS, WILL MAINTAIN REPORTABILITY ON BOTH PRODUCTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR LEAD DID EXHIBIT OUT-OF-RANGE PACE IMPEDANCE GREATER THAN 2,000 OHMS IN ASSOCIATION WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) APPROXIMATELY ONE MONTH AFTER THE CRT-D WAS IMPLANTED. THERE HAD BEEN NO ADVERSE PATIENT EFFECTS ASSOCIATED BEYOND THE SURGICAL INTERVENTION THAT OCCURRED FOR THE LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 0185| N118| 4517| H175| 4470