BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4678669 · Received April 10, 2015

    Report

    Report Number
    2182208-2015-01138
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    February 3, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER FROZE WHEN THE ANALYZER WAS STARTED AND WHEN GOING FROM VITATRON SCREEN TO MEDTRONIC SCREEN DUE TO THE LINK ELECTRONIC MODULE (LEM) PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED PRINTER ISSUE.

    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 THE PROGRAMMER FREEZES WHEN THE ANALYZER IS STARTED. THE PROGRAMMER ALSO FREEZES WHEN GOING FROM VITATRON SCREEN TO MEDTRONIC SCREEN. IT WAS ALSO REPORTED THE PRINTER IS NOT WORKING. THE PROGRAMMER WAS RETURNED FOR REPAIR AND TEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242120 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090CL

    Patients

    Seq Age Sex Outcome Treatment
    1