BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3211002 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08070
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRES WERE VERIFIED TO BE CRACKED. THIS RESULTED IN HIGH PACING AND SHOCK IMPEDANCE MEASUREMENTS. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RIGHT VENTRICULAR (RV) LEAD REVISION WAS SCHEDULED DUE TO GREATER THAN 200 OHM IMPEDANCE MEASUREMENTS. DURING THE REVISION PROCEDURE THE LEAD WAS SUCCESSFULLY REPLACED. DURING FINAL TESTING, THE RIGHT ATRIAL (RA) LEAD WAS RECONNECTED TO THE DEVICE HOWEVER NOISE AND GREATER THAN 2000 OHM PACING IMPEDANCE MEASUREMENTS WERE OBSERVED (THAT WERE NOT PRESENT PRIOR TO THE PROCEDURE). TESTING THROUGH THE PACING SYSTEM ANALYZER (PSA) REVEALED NORMAL VALUES WITH NO NOISE. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NORMAL MEASUREMENTS WERE NOTED WITH THE NEW DEVICE. A DEVICE HEADER ISSUE WAS SUSPECTED AND THE PREVIOUS DEVICE WAS RETURNED FOR ANALYSIS TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309893 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 0181| 4136| N118| 6996SQ| 4518| 0185| N164