BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160942 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02776
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 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 COULD NOT CONFIRM THE REPORTED EVENT; PROGRAMMER BOOTS UP AS EXPECTED. HOWEVER DURING INTERROGATION, RECEIVED A SYSTEM ERROR. HARD DRIVE RECONFIGURED, SOFTWARE RELOADED, AND PROGRAMMER INTERROGATED SUCCESSFULLY. PROGRAMMER COULD NOT CONNECT WIRELESSLY AT SYSTEMS TEST; RFT (RADIO FREQUENCY TRANSCEIVER) REPLACED TO RESOLVE WIRELESS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT COMPLETE THE BOOT UP PHASE. IT WOULD GET TO THE POINT WHERE IT SHOULD LOAD THE MODEL SCREEN, BUT NEVER DOES. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641895 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD