BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875144 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19066
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION, VIA A LATITUDE RED ALERT, THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED ONE LOW SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. A HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) AFTER THE ALERT AND INDICATED THAT ALL IMPEDANCE MEASUREMENTS PRIOR TO THE LOW IMPEDANCE MEASUREMENT WERE NORMAL AND STABLE AND INQUIRED ABOUT POSSIBLE CAUSES FOR ONE OUT OF RANGE MEASUREMENT. TS DISCUSSED THAT NEW SHOCK IMPEDANCE TEST USES A MUCH SMALLER AMOUNT OF ENERGY WHICH MAY PRODUCE ERRONEOUS MEASUREMENTS. TS RECOMMENDED WAITING 24 HOURS AND SEE IF IMPEDANCE MEASUREMENTS REMAIN STABLE. TS ALSO RECOMMENDED LOOKING AT PRESENTING AND STORED ELECTROGRAM'S FOR ANY SIGNS OF NOISE WHICH NECESSITATE BRINGING THE PATIENT IN PRIOR TO THE NEXT APPOINTMENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)