BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2040740 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01004
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 19, 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

    THERE IS NO FURTHER INFORMATION AVAILABLE. 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

    --

    Description of Event or Problem · 1

    ONE WEEK LATER, NEW INFORMATION WAS RECEIVED CONFIRMING ALL PRODUCTS WERE EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS NON BOSTON SCIENTIFIC SALES REPRESENTATIVE CALLED INQUIRING ABOUT LEAD SPECS AND STATED A LEAD EXTRACTION WOULD BE PERFORMED DUE TO AN INFECTION.

    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 66 YR Life Threatening| R MISMATCH| N119| 4135| E110| 0157| 4542