BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152115 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01172
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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
    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. CONCOMITANT PRODUCT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THAT THE PROGRAMMER GENERATED AN ERROR CODE WHEN IT WAS TURNED ON, BUT THE HARD DISK DRIVE WAS RECONFIGURED AND THE CURRENT SOFTWARE RELOADED. PROGRAMMER PASSED ALL FUNCTIONAL SYSTEMS TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR CODE WHEN IT WAS TURNED ON. IT WAS NOTED THAT THE PROGRAMMER WAS THEN UNABLE TO BE USED. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR CODE WHEN IT WAS TURNED ON. IT WAS NOTED THAT THE PROGRAMMER WAS THEN UNABLE TO BE USED. 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
    252803 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1