BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK ENCORE

    MDR report key: 4831467 · Received June 10, 2015

    Report

    Report Number
    3004593495-2015-00108
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    OSR
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS NEW OUT OF THE BOX AND WHEN BOOTED UP, AN ERROR CODE WAS DISPLAYED. THE PROGRAMMER WAS POWER CYCLED TWICE AND A DIFFERENT ERROR CODE WAS DISPLAYED EACH TIME. THE PROGRAMMER WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375724 CARELINK ENCORE PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS OSR PLEXUS MANUFACTURING SDN. BHD 29901

    Patients

    Seq Age Sex Outcome Treatment
    1