BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991270 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02161
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE STYLUS TOUCH PEN AND ARROW DID NOT ALIGN, AS A RESULT THE BEZEL OVERLAY ASSEMBLY WAS REPLACED AND CALIBRATED TO RESOLVE ALIGNMENT ISSUE. IT WAS ALSO NOTED THAT THE CHART RECORDER WAS OUT OF SPECIFICATION, AND THE ANALYZER FLEX CABLE WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    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. 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 PROGRAMMER'S TOUCH PEN STYLUS AND THE ARROW ON THE DISPLAY SCREEN DO NOT ALIGN. CHANGING OUT THE STYLUS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468605 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD