BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043593 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02136
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 28, 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

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT FOR HIGH SHOCK IMPEDANCES WAS DETECTED ON THIS RIGHT VENTRICULAR LEAD. NO INFORMATION COULD BE INITIALLY OBTAINED FROM THE FIELD ABOUT THE LEAD INFORMATION OR ANY REMEDIAL ACTION ON THE SYSTEM. HOWEVER, RECENT INFORMATION WAS OBTAINED ABOUT THE LEAD AND THE PHYSICIAN NOTED AT A FOLLOW UP THAT THE IMPEDANCE LEVELS HAVE RETURNED TO NORMAL AND THEREFORE NO EXTRA FOLLOW UP WILL BE REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147103 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1