BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 6287854 · Received January 30, 2017

    Report

    Report Number
    2182208-2017-00026
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    June 18, 2009
    Report Date
    June 18, 2009
    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 · 0

    FORM CODE: F77772. THESE EVENTS WERE REPORTED TO FDA ON (B)(6) 2017 WITHIN A RETROSPECTIVE SUMMARY REPORT. E2016027. THE FDA APPROVAL NUMBER FOR THIS SUMMARY REPORT IS (B)(4). THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED FOR PRODUCT CODE KRG IS 5302, INCLUDING THE 3500A EVENT AND EVENTS DETAILED. THIS RETROSPECTIVE REVIEW WAS PERFORMED FOLLOWING OUR FIRM¿S CHANGE IN MEDICAL DEVICE REPORTING CRITERIA. THESE REPORTS REPRESENT EVENTS WITH ALERT DATES IN THE TWO YEARS PRIOR TO THAT CHANGE IN REPORTING CRITERIA. PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE STYLUS DID NOT OPERATE IN THE UPPER LEFT CORNER OF THE DISPLAY SCREEN HOWEVER THE STYLUS WAS REPLACED AS A PREVENTIVE. THE PROGRAMMER PASSED ALL FINAL FUNCTIONAL AND SYSTEMS TESTS AND NO OTHER ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS TOUCH PEN WAS NOT OPERATING IN THE UPPER LEFT CORNER OF THE DISPLAY SCREEN. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71280 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

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