BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151736 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01270
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE DEVICE LOCKED UP WITH A WHITE SCREEN WHEN POWERED ON. AFTER MORE THAN 30 MINUTES THE SCREEN CHANGED TO AN ERROR. AS A RESULT THE HARD DRIVE WAS REIMAGED AND THE SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE HARD DRIVE WAS OUT OF SPECIFICATION AND THE FAN WAS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER FROZE "BY THE WHITE SCREEN" WHEN POWERED ON. THE PROGRAMMER WAS 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
    252515 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD