BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4131469 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13808
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCES OF GREATER THAN 2000 OHMS AND INTERMITTENT LOSS OF CAPTURE. SUBSEQUENTLY THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS LEAD WAS SURGICALLY ABANDONED. THE DEVICE WAS RE-IMPLANTED WITH A NEW RA LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611807 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4543| N119| 4470| T125| 1831| 0155| 1388T