BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2790448 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03307
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 16, 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.

    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): ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, BOTH SOFTWARE AND HARDWARE ARE FUNCTIONING AS NORMAL. IT WAS NOTED THAT THE FAN WAS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SCREEN LOCKED UP AFTER THE BOOT-UP, AND THAT IT FROZE UP BEFORE AND DURING DEVICE SESSIONS. IT WAS NOTED THAT THE PROGRAMMER WAS VERY RECENTLY BACK FROM A REPAIR OF THE EXACT SAME ISSUE. THE PROGRAMMER HAS BEEN RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WERE NO PATIENT COMPLICATIONS 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