BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2050637 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03071
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE INDICATED LESS THAN 6 MONTHS OF BATTERY REMAINING. AS A RESULT, A CHANGE OUT PROCEDURE WAS SCHEDULED. ON THE DAY OF THE SCHEDULED CHANGE OUT, THE DEVICE INDICATED 2 YEARS REMAINING. AS A RESULT, THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 83 YR (B)(4)| (B)(4)| (B)(4)