BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2053034 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04158
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 9, 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

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    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

    INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE INDICATED 1 YEAR OF LONGEVITY REMAINING. 6 MONTHS LATER, A STRESS TEST WAS BEING PERFORMED AND THE PATIENT'S HEART RATE WOULD NOT INCREASED. IT WAS DETERMINED THE DEVICE HAD TRIPPED END OF LIFE AND WAS PROGRAMMED VVI 50. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 79 YR Required Intervention 1298| (B)(4)| (B)(4)| (B)(4)