BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2905477 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14126
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    July 5, 2011
    Report Date
    October 11, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC FOR EVALUATION WHERE THE OUT OF RANGE MEASUREMENTS WERE NOT ABLE TO BE REPRODUCED. THE LOGBOOK SHOWED ONE OTHER MEASUREMENT THAT HAD REACHED OUT OF RANGE THREE MONTHS AFTER THE FIRST REGISTERED MEASUREMENT. ALL OTHER DAILY SHOCK IMPEDANCE MEASUREMENTS TREND WITHIN NORMAL LIMITS. SUBSEQUENTLY THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD FALLEN AROUND THE TIME OF THE OUT OF RANGE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12115 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 0180| 4135| E110