BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990530 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02240
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 4, 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 WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WAS FREEZING AND THAT THE PRINTER WAS NOT WORKING AND NO EVIDENCE WAS OBSERVED OF SOFTWARE CORRUPTION. THE LINK ELECTRONIC MODULE (LEM) PRINTED CIRCUIT BOARD (PCB) ASSEMBLY WAS REPLACED AND CALIBRATED, AND THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS FREEZING AND THAT THE PRINTER WAS NOT WORKING. FOLLOW-UP DETERMINED THAT THE PROGRAMMER WAS ABLE TO FINISH ITS SESSION BY BEING REBOOTED. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467015 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 SOFTWARE ANALYZER