BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162960 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03033
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 15, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE STYLUS SKIPPED A SECTION ON THE OVERLAY. AS A RESULT THE OVERLAY ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. IT WAS ALSO NOTED THAT THE POWER SUPPLY AND SYSTEM FAN WERE NOISY, AND THE TAB ON THE POWER CORD BAY DOOR WAS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS "CHECKED OUT" LAST WEEK, BUT WAS STILL NOT WORKING. EXACT ISSUE IS UNKNOWN. THE PROGRAMMER HAS BEEN RETURNED. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639279 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1