BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3971354 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-13711
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBLE CAUSES AND STATED THAT SINGLE COIL SHOCK LEAD IMPEDANCE MEASUREMENTS TEND TO RUN HIGHER. A LOCAL FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN PLANS TO PERFORM A COMMANDED SHOCK AT AN UNKNOWN FUTURE DATE. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED INDICATED THAT THE SYSTEM CONTINUED TO EXHIBIT HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. SUBSEQUENTLY, A SYNCHRONOUS SHOCK AT 41 JOULES (J) AND A DEFIBRILLATION THRESHOLD (DFT) TEST AT 31 J WERE PERFORMED. THE SHOCKING IMPEDANCE MEASUREMENT OBTAINED IN BOTH TESTS WERE WITHIN THE NORMAL RANGE. THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448363 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R 4470| 0292| E162