BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954117 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24157
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    June 1, 2012
    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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLINIC BROUGHT THE PATIENT AND PERFORMED INDUCTION TESTING TO EVALUATE LEAD INTEGRITY. INDUCTION TESTING REVEALED A SHOCK IMPEDANCE MEASUREMENT OF 35 OHMS. SINCE THE VALUE WAS IN-RANGE, THE PHYSICIAN OPTED TO CONTINUE MONITORING THE PATIENT AND NO CHANGES WERE MADE TO THE SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT FOR A LOW SHOCKING IMPEDANCE MEASUREMENT WAS RECEIVED THROUGH THE LATITUDE HOME MONITORING SYSTEM. UPON FOLLOW-UP, THE CLINICIAN ALSO OBSERVED THAT NOISE WAS RECORDED IN PLACE OF ONE DAILY MEASUREMENT; ALL OTHER RECENT SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL.. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED OPTIONS WITH THE CLINIC AND AT THIS TIME IT IS UNCLEAR IF THE PATIENT WILL BE BROUGHT IN FOR FURTHER TESTING. 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 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4542| N119| 0184