BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811225 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03685
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 10, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    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. EVALUATION SUMMARY: (B)(4) THE REPORTED SYSTEM ERRORS SEEM TO BE DUE TO A PCB (PRINTED CIRCUIT BOARD) ASSEMBLY FAILING TO RESPOND IN THE ALLOCATED TIME, HOWEVER THE PCB IN THE PROGRAMMER PASSED FUNCTIONAL TESTING. SYSTEM FAN IS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE AT THE BEGINNING OF AN INTERROGATION, REBOOTED FINE AND THEN RE-GENERATED THE ERROR WHEN THE INTERROGATION WAS ATTEMPTED AGAIN. THE SERVICE DISK WAS GOING TO BE RUN. IT WAS FURTHER REPORTED THAT A FEW DAYS LATER THE PROGRAMMER POWERED UP WITH A DIFFERENT ERROR. THE SERVICE DISK WAS RUN BUT THE PROGRAMMER LOCKED UP WITH THE ERROR AND WOULD NOT CLEAR. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD