BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2171031 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10426
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    January 9, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 WAS RECEIVED. FURTHER HIGH OUT OF RANGE MEASUREMENTS WERE REPORTED. THIS LEAD REMAINS IMPLANTED, HOWEVER THE DEVICE HAS BEEN REPROGRAMMED TO MONITOR ONLY. A FURTHER ECHO IS INTENDED IN THE NEXT FEW MONTHS. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS ISSUE WAS REVIEWED BY THE PHYSICIAN. THE DEVICE WAS REPROGRAMMED AND THE LEFT VENTRICULAR LEAD FUNCTION WAS DISABLED. THE DEVICE REMAINS IN SERVICE AND ABLE TO PROVIDE THERAPY. A LEAD REVISION WAS NOT PERFORMED AS AN ECHO REVEALED IMPROVED HEART STATUS. 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 0181

    Patients

    Seq Age Sex Outcome Treatment
    1