BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4131461 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13781
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    August 13, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE CLINICALLY OBSERVED ERROR MESSAGE WAS REPRODUCED. MEMORY REVIEW CONFIRMED THAT THE DEVICE UNDERWENT A RESET DUE TO MEMORY CORRUPTION WHICH RESULTED IN THE OBSERVED ERROR MESSAGE. FOLLOWING THE RESET, THE DEVICE REVERTED TO A SAFETY MODE WITH LIMITED PROGRAMMABILITY, IN WHICH SINGLE CHAMBER PACING THERAPY WAS AVAILABLE. THE ROOT CAUSE OF THE MEMORY CORRUPTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHEN ATTEMPTING TO PROGRAM THIS PACEMAKER PRIOR TO EXPLANT A WARNING MESSAGE WAS DISPLAYED INDICATING THE DEVICE WAS IN SAFETY CORE. THE FACILITY WAS ADVISED THAT IT WAS NOT POSSIBLE TO REPROGRAM THE DEVICE AND THAT IT SHOULD NOT BE IMPLANTED. THE DEVICE WAS RETRIEVED BY A LOCAL BOSTON SCIENTIFIC COMPANY REPRESENTATIVE AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610461 INGENIO IMPLANTABLE PULSE GENERATOR NVY GUIDANT CRM CLONMEL IRELAND J276

    Patients

    Seq Age Sex Outcome Treatment
    1 J276