BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875125 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18749
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 17, 2011
    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

    THE PATIENT WAS BROUGHT BACK IN CLINIC FOR TROUBLESHOOTING, BUT THE LOW SHOCK IMPEDANCE MEASUREMENTS WERE NOT REPRODUCIBLE. RECENT SHOCK IMPEDANCE MEASUREMENTS AVERAGE NEAR 30 OHMS, BUT TWO MEASUREMENTS BELOW 20 OHMS WERE NOTED IN THE LAST RECORDED DAILY MEASUREMENTS. THE PATIENT HAS NOT REQUIRED SHOCK THERAPY, AND THE PHYSICIAN HAS ELECTED TO MONITOR THE SITUATION AT THIS TIME. THE CLINIC PLANS TO RE-EVALUATE THE PATIENT IN ONE MONTH. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS, TRIGGERING A LATITUDE RED ALERT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOW SHOCK IMPEDANCE MEASUREMENTS HAVE CONTINUED ON THIS LEAD SINCE THE INITIAL OBSERVATION. RECENTLY, A DEFIBRILLATION THRESHOLDS TEST WAS PERFORMED AT A DEVICE CHANGEOUT FOR NORMAL BATTERY DEPLETION TO TEST THE INTEGRITY OF THE LEAD. THE PATIENT WAS SUCCESSFULLY CONVERTED WITH NO ADDITIONAL LEAD ISSUES. 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening 4549| H217| 4480| 0185