BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1864085 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15973
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    April 12, 2008
    Report Date
    August 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS RETURNED. 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 EXPLANTED, DUE TO A POCKET EROSION. 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 0882

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 0882| 292-07| 425-13