BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3971315 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14825
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. CUTS IN THE INSULATION AT 165 AND 180 MILLIMETERS (MM) FROM THE TERMINAL PIN WERE NOTED, MOST LIKELY DUE TO THE REMOVAL OF THE SUTURE SLEEVE. AN X-RAY DID NOT REVEAL ANY FRACTURE ON THE LEAD. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. A SURGICAL INTERVENTION WAS SUBSEQUENTLY PERFORMED. THE OUT OF RANGE MEASUREMENT WAS OBSERVED THROUGH PACING SYSTEM ANALYZER (PSA) TESTING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS FRACTURED AND WAS NOTED THROUGH FLUOROSCOPY. THE CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446883 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R 4543| 4555| 4548| N119| 0185| 4087| MISMATCH