BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910537 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15325
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS DURING MANUAL TESTING. THE LEAD WAS TESTED IN DIFFERENT VECTORS AND THERE WERE OUT OF RANGE MEASUREMENTS OBSERVED IN COIL TO CAN AND TRIAD. THE DAILIES WERE REPORTED TO BE TRENDED AROUND 60-75 OHMS. A SAVE ALL TO DISK WAS TO BE PERFORMED AND SENT IN FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED, DISK ANALYSIS WAS PERFORMED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE DIFFERENCES BETWEEN THE MANUAL TEST AND THE DAILY TEST, AND HOW THE DAILIES HAVE BEEN STABLE, IN THE 70S FOR THE LAST FEW MONTHS. ALSO DISCUSSED HOW THE MANUAL TEST MAY BE SKEWED BY READINGS CLOSE TO OR GREATER THAN 125 OHMS AS PART OF THE CALCULATION. THE FIELD REPRESENTATIVE WAS TO DISCUSS THE OPTIONS OF CONTINUING TO MONITOR OR COMMANDED SHOCK DELIVERY TO TEST THE SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WILL BE RE-EVALUATED IN THE NEAR FUTURE AND WILL CONTINUED TO BE FOLLOWED NORMALLY. NO INVASIVE TESTING HAS BEEN PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16685 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0275

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4469| 0275| E162