BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161336 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02708
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE ERROR, AS A RESULT THE HARD DRIVE WAS REIMAGED AND SOFTWARE WAS RELOADED. HARD DRIVE WAS ALSO REPLACED. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS LOOSE, THE KEYBOARD HAD A BROKEN LATCH, AND THE POWER CORD BAY DOOR HAD A BENT TAB. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER EXPERIENCED AN ERROR DURING BOOT UP AND HAD POSSIBLE REGISTRY CORRUPTION. THE PROGRAMMER WAS CYCLE POWERED AND THE ERROR RETURNED. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641863 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY (RF) HEAD, 2290 ANALYZER