BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211671 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08706
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    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

    UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO OUT OF RANGE SHOCKING IMPEDANCES ON THIS DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A FOLLOW UP WAS SCHEDULED. AT THIS TIME A FOLLOW UP HAS BEEN PERFORMED AND THE SYSTEM REMAINS IMPLANTED WITH HIGH TREND IMPEDANCE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311571 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1