BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3040847 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-04476
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PROCEDURE FOR A NON BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD, THIS DEVICE WAS FOUND TO HAVE A LOSE HEADER. IT WAS UNKNOWN IF THIS OCCURRED DURING THE REVISION PROCEDURE. THE DEVICE SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143539 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R MISMATCH| N119| 4076| 4542| H210| 6949| N140| 0293