BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860057 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01536
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS NOT ABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WAS UNABLE TO RUN THRESHOLD TESTS, ALTHOUGH ERRORS WERE FOUND IN TH ERROR LOG AND THE SOFTWARE WAS RELOADED AS A PREVENTIVE. ANALYSIS ALSO FOUND THAT THE DISPLAY DROPPED AND THAT THE FAN WAS NOISY, AND THE LOWER HINGES ON THE DISPLAY AND THE FAN WERE BOTH REPLACED TO RESOLVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RUN THRESHOLD TESTS AND THAT IT WOULD GENERATE AN ERROR MESSAGE OF "NOISE" ALTHOUGH THE ELECTROGRAMS SHOWED NO NOISE AND ALL LIGHTS WERE LIT ON THE RADIOFREQUENCY PROGRAMMER HEAD. BOTH THE WAND AND THE STYLUS WERE CHANGED OUT IN ORDER TO ELIMINATE THEM AS POSSIBLE SOURCES OF THE ISSUE. FOLLOW-UP DETERMINED THAT THE ELECTROGRAMS WERE NOT ALWAYS VISIBLE ON THE PROGRAMMER DISPLAY WHEN THE ERROR MESSAGE APPEARED AND IT WAS SPECULATED THAT THE RADIOFREQUENCY (RF) PROGRAMMER HEAD CONNECTION ON THE PROGRAMMER MAY BE CAUSING IT TO LOSE TELEMETRY WITH THE DEVICE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RUN THRESHOLD TESTS AND THAT IT WOULD GENERATE AN ERROR MESSAGE OF "NOISE" ALTHOUGH THE ELECTROGRAMS SHOWED NO NOISE AND ALL LIGHTS WERE LIT ON THE RADIOFREQUENCY PROGRAMMER HEAD. BOTH THE WAND AND THE STYLUS WERE CHANGED OUT IN ORDER TO ELIMINATE THEM AS POSSIBLE SOURCES OF THE ISSUE. FOLLOW-UP DETERMINED THAT THE ELECTROGRAMS WERE NOT ALWAYS VISIBLE ON THE PROGRAMMER DISPLAY WHEN THE ERROR MESSAGE APPEARED AND IT WAS SPECULATED THAT THE RADIOFREQUENCY (RF) PROGRAMMER HEAD CONNECTION ON THE PROGRAMMER MAY BE CAUSING IT TO LOSE TELEMETRY WITH THE DEVICE. 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
    339678 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD| 2067 RADIOFREQUENCY PROGRAMMER HEAD