BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1861091 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15390
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED. THE POCKET WAS CLEANED AND THE PATIENT IS ON ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE NOTED WITH THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS SYSTEM HAD AN INFECTION. AS A RESULT, AN EXTRACTION PROCEDURE HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS HAVE BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening MISMATCH| (B)(4)| (B)(4)| 1290| 466