BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162654 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01270
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MILACA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLUS WOULD NOT WORK. THE PEN WAS REPLACED WITH 4 DIFFERENT PENS, AND STILL NO REACTION ON THE SCREEN. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643905 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC MILACA, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1