BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991808 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02094
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, AFTER REMOVING THE DIAGNOSTIC INFORMATION THE DEVICE BOOTED TO AN ERROR AND THE MEDIA PROCESSING UNIT BOARD WAS THEREFORE REPLACED TO RESOLVE. ANALYSIS ALSO FOUND THAT THE PROGRAMMER CASES WERE CRACKED AT THE HANDLE AREA, THAT THERE WAS CORROSION ON THE POWER SUPPLY, THAT THE FLOPPY DRIVE WAS MISSING ITS FRONT TRIM PIECE, THAT THE SYSTEM FAN WAS INTERMITTENTLY NOISY AND THAT THE PROGRAMMER WAS OUT OF SPECIFICATION ON ITS LEFT ANTENNA CONNECTED FUNCTIONAL TEST. THE ANTENNA WAS TIGHTENED TO RESOLVE AND ALL OTHER AFFECTED PARTS WERE REPLACED. PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFULLY UPDATING THE PROGRAMMER SOFTWARE VIA THE SOFTWARE DISTRIBUTION NETWORK USING HIGH SPEED INTERNET, THE PROGRAMMER WAS POWERED OFF AND BACK ON BUT IT POWERED ON TO A BLACK SCREEN. THE SERVICE DISK WAS RUN BUT IT DID NOT RESOLVE THE SITUATION. THE PROGRAMMER HAS BEEN 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
    467209 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD