BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991224 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02174
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE STYLUS WAS NOT ABLE TO CALIBRATE WITH THE OVERLAY/BEZEL AND THEREFORE THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND CALIBRATED. AN ERROR WAS ALSO FOUND IN THE LOGS AND THEREFORE IT WAS RECONFIGURED AND THE SOFTWARE RELOADED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURSOR WAS OFF BY 3 INCHES FORM WHERE THE CALLER PUT THE STYLUS. THE CALLER TRIED CALIBRATING THE STYLUS BY COVERING TIP OF STYLUS AND USING OPPOSING FINGER AS STYLUS TO SEE IF THEY COULD GET THE CURSOR TO THE PROGRAMMER ICON. TECHNICAL SUPPORT (TS) RECOMMENDED THE PROGRAMMER BE RETURNED FOR REPAIR IF CALIBRATION IS NOT SUCCESSFUL. THE STATUS OF THE PROGRAMMER IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURSOR WAS OFF BY 3 INCHES FORM WHERE THE CALLER PUT THE STYLUS. THE CALLER TRIED CALIBRATING THE STYLUS BY COVERING TIP OF STYLUS AND USING OPPOSING FINGER AS STYLUS TO SEE IF THEY COULD GET THE CURSOR TO THE PROGRAMMER ICON. TECHNICAL SUPPORT (TS) RECOMMENDED THE PROGRAMMER BE RETURNED FOR REPAIR IF CALIBRATION IS NOT SUCCESSFUL. THE STATUS OF THE PROGRAMMER IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472566 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD