BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4831663 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01612
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 15, 2015
    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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE PROGRAMMER WOULD NOT COMPLETE BOOT UP, STAYED ON PLEASE WAIT SCREEN; SOFTWARE WAS RELOADED TO RESOLVE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379407 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD