BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1864176 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16059
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 9, 2010
    Report Date
    April 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO THE EXPLANTING FACILITY'S PATHOLOGY DEPARTMENT. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED (B)(6) LATER DUE TO A PATIENT INFECTION. IT WAS REPORTED THE PATIENT EXPERIENCES RECURRENT (B)(6).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE AND A RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE ASSOCIATED WITH A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. A HEALTH CARE PROVIDER (HCP) REPORTED THE IMPEDANCE MEASUREMENTS HAD BEEN TRENDING UPWARD SINCE IMPLANT 14 MONTHS PREVIOUS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED TROUBLESHOOTING STRATEGIES. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS CAPPED, SURGICALLY ABANDONED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    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 59 YR Other (B)(4)| (B)(4)| (B)(4)| (B)(4)