BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 5370911 · Received January 15, 2016

    Report

    Report Number
    2124215-2015-14429
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND TROUBLESHOOTING IDEAS. THE CALLER WILL CONSULT THIS PATIENT'S PHYSICIAN. 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 SYSTEM HAS BEEN EXHIBITING RISING SHOCK IMPEDANCE MEASUREMENTS. MOST RECENTLY, THERE WAS A RED ALERT GENERATED FOR A MEASUREMENT GREATER THAN 125 OHMS AND TODAY, THE MEASUREMENT WAS 133-135 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29514 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR