BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2697834 · Received August 14, 2012

    Report

    Report Number
    2182208-2012-02749
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    June 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. DRIVE CORRUPTION FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN SELECTED THE VITATRON SCREEN AND PROGRAMMER LOCKED UP ON BLANK SCREEN WHEN GOING BACK TO THE MEDTRONIC SCREEN. IT WAS ALSO REPORTED THE PROGRAMMER ONLY HAS GRAY SCREEN WITH ONLY THREE ICONS ON SCREEN. NO AMOUNT OF REBOOTING CLEARED THEM. THIS HAPPENED WHEN SWITCHING BETWEEN VITATRON AND MEDTRONIC APPLICATIONS. IT WAS ALSO REPORTED WHEN PROGRAMMER WAS POWERED ON, IT DID NOT COME UP TO THE MODEL SELECT SCREEN, ONLY TO A BLANK TAN SCREEN WITH NO ICONS OR ANYTHING. RUNNING THE PROGRAMMER SERVICE DISK DID NOT CORRECT THE ISSUE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other