BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAMMER

    MDR report key: 12696721 · Received October 26, 2021

    Report

    Report Number
    2182208-2021-04228
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    July 23, 2021
    Report Date
    October 26, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT OF THE PROGRAMMER¿S PERCEPTION MEASUREMENT FAILED. THE PROGRAMMER PASSED INCOMING FUNCTIONAL TESTS. IT WAS ALSO DETERMINED AT ANALYSIS THAT THE TOUCHSCREEN WAS MISSING SOME LINES AND THE CURSOR WAS JUMPING. THE CARD BUS SLOT WAS DEFECTIVE, AND THE PAPER TRAY WAS NEARLY EMPTY. THE SOFTWARE WAS REINSTALLED AND UPDATED TO THE NEWEST VERSION. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE THEN PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER¿S PERCEPTION MEASUREMENT FAILED, THE ICON REMAINED GREYED OUT AND COULD NOT BE SELECTED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND HEMOSTASIS MANAGEMENT SYSTEM(HMS) DEVICES. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595186 CARELINK PROGRAMMER PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1