BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161008 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02747
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 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 VERIFIED THE PROGRAMMER BOOTED UP TO A SYSTEM ERROR; HARD DRIVE RECONFIGURED AND SOFTWARE RELOADED TO RESOLVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLACK SCREEN OF DEATH (BSOD) WAS THE FIRST SCREEN THAT CAME UP AFTER THE PROGRAMMER WAS TURNED ON. THE PROGRAMMER DID NOT GO TO ANY OTHER SCREEN. THE RECOVERY DISK WAS UNSUCCESSFULLY USED. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTEDAS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641252 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIO FREQUENCY HEAD