BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161289 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02713
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    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 FOUND THE PROGRAMMER POWERS UP WITHOUT AN ERROR, HOWEVER ERRORS ARE RECENTLY RECORDED IN THE PROGRAMMER ERROR LOG. ANALYSIS ALSO FOUND THE SYSTEM FAN WAS NOTICEABLY LOUD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED SEVERAL BLACK ERROR SCREENS RECENTLY DURING THE BOOT UP PHASE. THE SERVICE DISK WAS RAN AND IT WORKED OK FOR ABOUT A WEEK AND THEN THE ERROR RETURNED AGAIN. TECHNICAL SERVICES (TS) STATED THAT THE LINK ELECTRONICS MODULE (LEM) BOARD MAY BE BAD AND TO RETURN THE PROGRAMMER. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638116 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIO FREQUENCY HEAD