BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853685 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15026
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THERE HAVE BEEN NO RECENT SHOCKS DELIVERED SINCE INDUCTION; THEREFORE, NO MEASUREMENTS WITH A DELIVERED SHOCK. TECHNICAL SERVICES (TS) DISCUSSED HOW IF AN OUT-OF-RANGE SHOCK LEAD IMPEDANCE WAS REPORTED WITH A SUCCESSFUL DEFIBRILLATION THRESHOLD TEST; WE CAN STILL NOT GUARANTEED A SHOCK WILL WORK IN THE FUTURE. ESPECIALLY IF IT FALLS OUTSIDE OF OUR IN-RANGE LABELING. IF AN IN-RANGE SHOCK LEAD IMPEDANCE IS REPORTED, WE CAN NOT GUARANTEE FUTURE SUCCESS SINCE THERE HAS BEEN AN OUT OF RANGE VALUE. IN ANY CASE, IT WILL BE PHYSICIAN DISCRETION IF THEY'D LIKE TO MONITOR AND/OR REPLACE DEVICE AND/OR LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR H179| 4517| MISMATCH| 0185