BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1954191 · Received January 10, 2011

    Report

    Report Number
    2124215-2011-00310
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND END OF LIFE (EOL) WITHIN ONE DAY OF EACH OTHER. THE PATIENT IMPLANTED WITH THIS DEVICE WAS PRESENTED WITH A DECREASED HEART RATE. ADDITIONALLY, IT WAS OBSERVED THAT THRESHOLD MEASUREMENTS WERE INCREASED. TECHNICAL SERVICES (TS) DISCUSSED OBSERVATIONS. A DEVICE CHANGE OUT PROCEDURE WAS PLANNED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)