BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3904337 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10153
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    August 10, 2012
    Report Date
    April 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 THE LEFT VENTRICULAR (LV) LEAD AND DEFIBRILLATOR EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS THAT WERE REPRODUCIBLE IN THE CLINIC. UPON EVALUATION, IT WAS ALSO NOTED THAT THE LV LEAD THRESHOLD MEASUREMENTS HAD INCREASED AND LOSS OF CAPTURE WAS SUSPECTED. THE LEAD WAS MODIFIED ELECTRICALLY WITH GOOD IMPEDANCE AND THRESHOLD MEASUREMENTS AND THE PHYSICIAN MONITORED THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT OVER ONE AND A HALF YEARS LATER THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED VIA A LASER DUE TO THE HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, HIGH THRESHOLD MEASUREMENTS, OVERSENSING OF NOISE AND LOSS OF CAPTURE. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384321 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R N119| 0185| 4555| 4470