BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1862121 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15620
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1294

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 4261| 1274| 5068| 1294