BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4163236 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02998
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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

    PRODUCT EVENT SUMMARY: ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT BOOT UP. DURING ANALYSIS THE PROGRAMMER GENERATED A 0502 ERROR AND THEREFORE THE MEDIA PROCESSING UNIT WAS REPLACED. IT WAS FURTHER NOTED THAT DUE TO INFORMATION NOT BEING ABLE TO BE PULLED THE HARD DRIVE WAS ALSO REPLACED AND SAVED, AND THE SYSTEM FAN WHICH WAS FOUND TO BE NOISY WAS ALSO REPLACED.

    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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT BOOT UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644548 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY PROGRAMMER HEAD