BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAMMER

    MDR report key: 8821550 · Received July 24, 2019

    Report

    Report Number
    2182208-2019-01336
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 20, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE COMPLAINT WAS CONFIRMED IN THE SOFTWARE LOG, BUT OVERHEATING WAS UNABLE TO BE REPRODUCED. THE ISSUE WAS ATTRIBUTED TO THE MOTHER BOARD BEING OUT-OF-SPECIFICATION. A PRINTER SPEED KEY FAILED TESTING. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE HARD DRIVE WAS RECONFIGURED, THE SOFTWARE WAS RELOADED AND UPDATED, AND THE DEVICE PASSED ALL FINAL FUNCTIONAL AND SYSTEMS TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    19-AUG-2019 IT WAS FURTHER REPORTED THAT THE PROGRAMMER DISPLAYED A "SERIOUS PROGRAMMER PROBLEM" ERROR MESSAGE. THE PROGRAMMER WAS RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN OVERHEATING MESSAGE, AND A GAVE A PROMPT TO RESTART. THE PROGRAMMER WAS THEN RESTARTED, AND THERE WERE NO ISSUES OR OVERHEATING VISIBLE. THE PROGRAMMER WAS OPERATING AS EXPECTED, AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616018 CARELINK PROGRAMMER PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1