BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875105 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19027
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE PATIENT LEAVING THE OPERATING ROOM, A SINGLE SHOCK IMPEDANCE WITHIN THE ACCEPTABLE RANGE WAS MEASURED. THE AVAILABLE INFORMATION SUGGESTS THE SYSTEM REMAINS IMPLANTED WITHOUT FURTHER COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING AN IMPLANT PROCEDURE, THIS CARDIAC SYSTEM HAD A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. SEVERAL TROUBLESHOOTING ATTEMPTS WERE TAKEN, AND THE LEAD WAS DISCONNECTED AND RECONNECTED TO THE DEVICE. THE SHOCK IMPEDANCE MEASUREMENT WAS STILL OUT OF RANGE, AND A DEFIBRILLATION THRESHOLD TEST COULD NOT BE PERFORMED. THE PHYSICIAN ELECTED TO ACCEPT THE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1