BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151503 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01157
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 2067 RADIO FREQUENCY PROGRAMMER HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; PROGRAMMER POWERS UP WITH BLACK SCREEN AND "F1-F12" ON IT DUE TO CONNECTION BETWEEN A PRINTED CIRCUIT BOARD ASSEMBLY TO THE HARD DRIVE BEING LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER BOOTED UP TO A BLACK SCREEN WITH NUMBERS ON IT, AND THAT THE SCREEN LOOKED LIKE IT HAD A "MAZE" ON IT. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252782 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1