BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161330 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02706
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    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. PRODUCT EVENT SUMMARY: DURING ANALYSIS THE PROGRAMMER DID NOT RECEIVE AN ERROR DURING BOOT UP AS THE CUSTOMER REPORTED, HOWEVER A RECENT ERROR MESSAGE WAS CONFIRMED IN THE GET LOGS ERROR FILE AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS RESEATED AND RECALIBRATED. ADDITIONALLY THE SOFTWARE WAS RELOADED AS A PREVENTIVE MEASURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER RECEIVED AN ERROR DURING BOOT UP. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641861 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1