BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153617 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01452
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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 FOUND THAT THE ANALYZER SCREW WAS LODGED BUT ABLE TO BE REMOVED. THE ANALYZER WOULD NOT COMMUNICATE WITH THE PROGRAMMER AND IT FAILED MOST FUNCTIONAL TESTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PRODUCT ID 2090W PROGRAMMER; PRODUCT ID 2067L RF HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW COULD NOT BE RETRACTED TO CHECK THE ANALYZER. THE ANALYZER IS NOT CONNECTED. THE ANALYZER WAS TURNED ON TO DO A CASE/CHECK/TEST AND UNABLE TO FIX. IT WAS ALSO REPORTED THE LID TO KEYBOARD NEEDS TO BE REPAIR. THE ANALYZER AND PROGRAMMER WERE 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
    254246 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. R2290

    Patients

    Seq Age Sex Outcome Treatment
    1