BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921797 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11039
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE DEVICE WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE GREATER THAN 2,000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT PATIENT IS NOT NORMALLY PACED AND HAS AN INTRINSIC HEART RATE OF APPROXIMATELY 85 BEATS PER MINUTE (BPM). FURTHER, TS DISCUSSED THAT THE MAIN ISSUE IS THAT THE DAILY MEASUREMENT WILL BE OOR FOR THE RV PACE IMPEDANCE AND ADVISED THAT PHYSICIAN MIGHT CONSIDER LEAD REVISION OR LEAVE THE LEAD AS IT IS AS ALL OTHER MEASUREMENTS WERE GOOD. ADDITIONAL INFORMATION OBTAINED FROM FIELD REPRESENTATIVE AND INDICATED THAT THE CAUSE WAS UNDETERMINED, HOWEVER WILL CONTINUE TO WATCH LEAD. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400440 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 0285| E050