BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151949 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01203
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    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 CONFIRMED THE REPORTED EVENT, THE PROGRAMMER WOULD NOT LOAD SOFTWARE FOR AN UPGRADE, THE HARD DISK DRIVE WAS REIMAGED AND SOFTWARE WAS RELOADED. THE STYLUS WAS NOT FUNCTIONING WELL, THE STYLUS WAS NOT SEATED, SO THE STYLUS WAS REINSTALLED AND SEATED. THE UPPER CASE WAS BROKEN, THE POWER CORD DOOR WAS DAMAGED, THE HINGE PLATE SCREW WAS MISSING AND THE RIGHT ANTENNA COAX CABLE WAS DAMAGED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT LOAD SOFTWARE FOR AN UPGRADE FROM THE UNIVERSAL SERIAL BUS (USB), AND THE TOUCH PEN (STYLUS) WAS NOT FUNCTIONING WELL BECAUSE THE STYLUS CONNECTOR WAS BAD. VARIOUS ERROR MESSAGES WERE ALSO DISPLAYED DURING POWER UP. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252397 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1