BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 7491801 · Received May 7, 2018

    Report

    Report Number
    2182208-2018-00848
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 7, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: ANALYSIS CONFIRMED THAT THE SOFTWARE COULD NOT BE UPDATED. IT WAS ALSO FOUND THAT THE PROGRAMMER'S STYLUS WAS INOPERATIVE. ADDITIONALLY, THE HARD DRIVE HEALTH (HDH) WAS LESS THAN 100%. THE LOWER DISPLAY HINGES WERE WORN. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE WAS RE-CALIBRATED AND FUNCTIONALLY TESTED. THE DEVICE PASSED ALL FINAL TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO COMPLETE SOFTWARE UPDATE. THE PROGRAMMER HAS BEEN RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332527 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090CL

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY HEAD, 2290 ANALYZER