BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991298 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02164
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 5, 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 CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER HAD A LONG BOOT TIME AND THEREFORE THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS ALSO FOUND THAT THE SOLDER JOINTS OF THE RADIOFREQUENCY HEAD CONNECTORS WERE CRACKED AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS REPLACED AND CALIBRATED, AND THAT THE DISPLAY SCREEN DROPPED AND THAT THE SYSTEM FAN WAS NOISY. THE LOWER DISPLAY HINGES AND THE FAN WERE REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A SLOW BOOT. THE SERVICE DISK WAS RUN BUT IT DID NOT RESOLVE THE ISSUE. FOLLOW-UP DETERMINED THAT THE PROGRAMMER WAS ABLE TO FUNCTION NORMALLY ONCE IT COMPLETED THE BOOT. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467059 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD