BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151706 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07891
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    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

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S DEFIBRILLATION LEAD HAD EXHIBITED A HIGH IMPEDANCE MEASUREMENT WHICH RESULTED IN A RED ALERT VIA LATITUDE. THERE WAS NO PRIOR OBSERVATIONS THAT THE MEASUREMENTS HAD BEEN INCREASING AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS INSTRUCTED TO FOLLOW UP AS USUAL AND WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0137

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR E102| 0137