BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860402 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01481
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 2290 PACING SYSTEM ANALYZER. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE LEFT PART OF THE SCREEN WAS OUT OF CALIBRATION, AS A RESULT THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. IT WAS ALSO NOTED THAT THE POWER CORD BAY DOOR WAS BROKEN, THE MEDIA BAY DOOR WAS BROKEN, AND THE PROGRAMMER POWERS UP WITH A RESTART ERROR. THE HARD DRIVE WAS RECONFIGURED AND SOFTWARE WAS RELOADED TO ADDRESS ERRORS.

    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 LEFT PART OF THE SCREEN WAS OUT OF CALIBRATION. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342877 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RADIO FREQUENCY (RF) HEAD