BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1781234 · Received August 3, 2010

    Report

    Report Number
    2124215-2010-15127
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN INITIAL VISUAL INSPECTION OF THIS DEVICE IDENTIFIED NO ANOMALIES. A REVIEW OF DEVICE MEMORY CONFIRMED THE OUT OF RANGE ATRIAL IMPEDANCE MEASUREMENTS. THE RA SETSCREW WAS REMOVED AND BOTH THE SETSCREW AND ASSOCIATED CONNECTOR BLOCK WERE MICROSCOPICALLY EXAMINED. THE SETSCREW WAS CONFIRMED TO EXHIBIT SIGNS OF CROSS-THREADING. THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED PER AUTOMATED TESTING. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AFTER A PROBLEM WITH RIGHT ATRIAL (RA) PACING AND RA PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. WHEN THE POCKET WAS REOPENED, THE COMPETITIVE RA LEAD FELL OUT OF THE DEVICE HEADER WHILE APPLYING A SMALL AMOUNT OF TRACTION. THE RA SETSCREW WAS FOUND TO BE IN THE UP POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION. THE PHYSICIAN EXPLANTED THIS DEVICE AND RETURNED IT FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R 0185| 0175| 4543| 1688TC| N119| 4592