BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992518 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02388
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 POWERED UP TO A BLACK SCREEN AND FOREIGN LANGUAGES. TECHNICAL SUPPORT (TS) TOLD THE CALLER TO CONTACT THEIR LOCAL MEDTRONIC REPRESENTATIVE TO HAVE IT REPLACED OR HAVE THE SERVICE DISK RAN. THE STATUS OF THE PROGRAMMER IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467305 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1