BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152903 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01364
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 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

    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, AS A RESULT THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN COULD NOT BE CALIBRATED, AND THE TOUCH PEN MUST BE TWO TO THREE INCHES AWAY FROM THE SCREEN IN ORDER TO ACTIVATE THE TASK ICON. IN ADDITION, SOME AREAS OF THE SCREEN DID NOT GET A RESPONSE. 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
    254735 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

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