BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4163418 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02978
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED SYSTEM ERROR; HARD DRIVE RECONFIGURED AND SOFTWARE RELOADED TO RESOLVE. ANALYSIS WAS NOT ABLE TO CONFIRM THE PROGRAMMER SHUTTING DOWN, OR NOT BEING ABLE TO POWER UP AT THE BENCH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DISPLAYED AN ERROR CODE AFTER START. IT WAS ALSO REPORTED THE PROGRAMMER CANNOT POWER ON WITH THE RF (RADIO FREQUENCY) HEAD. THE PROGRAMMER AND RF HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639828 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD