BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992599 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02378
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER BOOTS TO A SYSTEM ERROR; MPU (MICROPROCESSOR UNIT) PRINTED CIRCUIT BOARD ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. PRODUCTS: 229047 ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR WHILE IT WAS CONNECTED TO THE SOFTWARE DISTRIBUTION NETWORK (SDN) AND "SEARCHING FOR NETWORK". IT WAS ALSO REPORTED DURING SDN (SOFTWARE DISTRIBUTION NETWORK) UPDATE, THE PROGRAMMER FROZE. AFTER 24 HOURS OF WAITING, THE PROGRAMMER WAS RESTARTED. AT BOOT UP AN ERROR DISPLAYED AND NOTHING ELSE HAPPENED. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470566 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD