BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3989612 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02030
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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: ANALYSIS CONFIRMED THE REPORTED EVENT; PROGRAMMER KEEPS ATTEMPTING TO BOOT UP AND NEVER FULLY BOOTS UP AND DURING THE PROCESS VITATRON AND MEDTRONIC ARE DISPLAYED BRIEFLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WILL NOT BOOT TO EITHER MEDTRONIC OR VITATRON SCREEN, IT JUST KEEPS TOGGLING AND GOING TO A BLACK SCREEN. IT WAS ALSO REPORTED THE PROGRAMMER HAD BEEN IN THE VITATRON SCREEN AND USER TRIED TO GO BACK TO THE MEDTRONIC SCREEN WHEN THE PROGRAMMER BEGAN "BOUNCING" BACK AND FORTH AND WOULD NOT SETTLE ON EITHER SCREEN. ALL PERIPHERALS AND POWER WERE DISCONNECTED. AFTER WAITING, POWER WAS RECONNECTED AND PROGRAMMER TURNED ON, BUT STILL PROGRAMMER WOULD NOT BOOT UP. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463618 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA4

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD