BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3771420 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09263
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    June 28, 2012
    Report Date
    May 4, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DETECTED AN INCREASED RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. TACHY THERAPY WAS REPROGRAMMED TO OFF, DUE TO A SUSPECTED RV LEAD FRACTURE. A LEAD REVISION PROCEDURE WAS PERFORMED. ONCE THE DEVICE POCKET WAS OPEN, A 90 DEGREE KINK IN THE RV LEAD WAS OBSERVED. ONCE THE KINK WAS RELEASED, THE IMPEDANCE MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. NO FURTHER COMPLICATIONS WERE OBSERVED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249226 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 0185| H227| MISMATCH| 4555| E030| N119| 4592| 1853| 4047| 4087