BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153549 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01445
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 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 CONFIRMED THE ERROR WHEN INTERROGATED AN IMPLANTABLE CARDIAC DEVICE. AS A RESULT THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WAS "ACTING UP," AFTER DOING A SOFTWARE UPGRADE VIA USB (UNIVERSAL SERIAL BUS). INTERROGATION OF A DEVICE WAS ATTEMPTED, AND AN ERROR MESSAGE WAS RECEIVED. THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS DISCONNECTED AND POWER CYCLED, BUT THE SAME ISSUE OCCURRED. THE SERVICE DISK WAS ATTEMPTED WITHOUT SUCCESS. ANOTHER PROGRAMMER WAS USED TO DO THE SESSION. THE PROGRAMMER WAS SUBSEQUENTLY RETURNED WITH INFORMATION STATING THE PROGRAMMER WOULD NOT INTERROGATE ANY DEVICE AFTER DOING THE SOFTWARE UPGRADE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258538 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

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