BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3043592 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02568
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS CONFIRMED TO BE IN SAFETY MODE. REVIEW OF STORED MEMORY VERIFIED THAT THE DEVICE EXPERIENCED THREE SYSTEM FAULTS OCCURRED WHICH CAUSED THE DEVICE TO GO INTO SAFETY MODE. ALL THREE FAULTS OCCURRED FOLLOWING A START PES USER MESSAGE AS A RESULT OF THE USER ATTEMPTING TO BREAK THE PATIENT¿S ATRIAL ARRHYTHMIA WITH COMMANDED PES INDUCTION. ENGINEERS WERE ABLE TO REPRODUCE THE DEVICE REVERTING TO SAFETY MODE USING THE SAME PES INDUCTION PARAMETERS THAT WERE OBTAINED FROM THE DEVICE¿S MEMORY. THIS FAMILY OF DEVICES HAS BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN APPROXIMATELY 48 HOURS, A DEVICE WILL ENTER SAFETY MODE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ---

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PATIENT FOLLOW UP, THIS DEVICE ENTERED SAFETY MODE AND DISPLAYED A FAULT MESSAGE ON THE PROGRAMMER. JUST PRIOR TO ENTERING SAFETY MODE, ELECTRICAL MEASUREMENTS HAD BEEN PERFORMED ON THE DEVICE WITHOUT ANY ISSUES; HOWEVER, THE TELEMETRY COMMUNICATION WAS NOT OPTIMAL. THE FAULT MESSAGE WAS SENT TO BOSTON SCIENTIFIC ENGINEERING FOR FURTHER ANALYSIS. THE DATA WAS REVIEWED AND AN ENGINEER DISCUSSED THAT THE DEVICE ENTERED SAFETY MODE AS IT EXPERIENCED THREE FAULTS THAT EACH LED TO A SYSTEM RESET WITHIN A 48 HOUR PERIOD. THIS COULD INDICATE THAT THE DEVICE HAD NOT COMPLETED TASKS IN A SPECIFIED PERIOD OF TIME OR THERE WAS A POSSIBLE MEMORY CORRUPTION. IT WAS FURTHER DISCUSSED THAT THE DEVICE SHOULD BE REPLACED AND RETURNED FOR DETAILED LABORATORY ANALYSIS. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146705 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J173

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R