BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151858 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01228
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT CONCERNING THE PROGRAMMER BEING STUCK ON THE OPENING SCREEN. PIN RECONFIGURATION WAS COMPLETED AND SOFTWARE WAS RELOADED AS A PREVENTATIVE. IT WAS ALSO NOTED THAT THE PROGRAMMER ANALOG CONNECTOR WAS OUT OF SPECIFICATION AND WILL NOT RECEIVE A CONNECTING CABLE CONNECTOR, THE POWER CORD DOOR WAS DAMAGED, THE KEYBOARD WAS DAMAGED NEAR THE ESCAPE KEY, THE EXTERNAL INSULATION WAS CUT ON THE POWER CORD, AND THE LEFT KEYBOARD HINGE WAS BROKEN.

    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 2067 RF HEAD; PRODUCT ID 229047 ANALYZER. (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 PROGRAMMER IS STUCK ON THE OPENING SCREEN. THE HOUR GLASS DOES NOT GO AWAY (FROZEN). IT WAS ALSO REPORTED THE POWER CORD IS CUT. 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
    253256 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1