BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780513 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12809
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    May 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT WAS EVALUATED IN THE CLINIC AND THE SHOCK LEAD IMPEDANCE WAS AROUND 100 OHMS. NO FURTHER TESTING WILL BE PERFORMED AT THIS TIME. THE PHYSICIAN PLANS TO CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD CONTINUES TO HAVE OUT OF RANGE IMPEDANCES, TRENDING FROM 100 OHMS TO 125 OHMS. THE PATIENT RECENTLY RECEIVED TACHYCARDIA THERAPY IN WHICH THEY RECEIVED FIVE SHOCKS. THE SHOCKS RETURNED IMPEDANCES OF 80 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE PATIENT'S LEAD IS CONNECTED TO A COMPETITOR'S PRODUCT. AT THIS TIME, NO ADVERSE PATIENT EFFECTS HAVE BEEN 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
    1 281 MO 0185| MISMATCH| T175