BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3043250 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03730
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    September 12, 2012
    Report Date
    March 5, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS MONITORED OVER NIGHT AND NO FURTHER EPISODES WERE OBSERVED. THE DEVICE WAS PROGRAMMED TO THE ORIGINAL SETTINGS FROM PRIOR TO THE LEAD REPLACEMENT PROCEDURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. WHILE CLOSING THE POCKET, NOISE WAS OVERSENSED ON THE RIGHT VENTRICULAR (RV) WHICH RESULTED IN PACING INHIBITION AND ASYSTOLE FOR GREATER THAN TWO CONSECUTIVE SECONDS. ADDITIONALLY, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND AN INAPPROPRIATE SHOCK WERE DELIVERED. STRIPS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW. ANALYSIS OF THE STRIPS REVEALED THE OVERSENSING MAY HAVE BEEN DUE TO AIR BUBBLES IN THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147215 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L 1296| 4457| 4470| 4549| 4543| 0185| N119