BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990774 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02225
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT OF A LONG BOOT TIME AND THEREFORE THE HARD DRIVE WAS REIMAGED AND THE SOFTWARE RELOADED. ANALYSIS ALSO NOTED THAT THE KEYBOARD WAS STARTING TO PULL APART NEAR THE RIGHT HINGE PIN, THAT THE STYLUS TIP WAS BROKEN AND NOT WORKING AND THAT THE SYSTEM FAN WAS NOISY AND ALL WERE REPLACED, AND THE STYLUS CALIBRATED. IT WAS FURTHER NOTED THAT THE DEVICE HAD TWO EXCEPTIONS IN THE ERROR LOG AND THAT HARD DRIVE PERFORMANCE WAS AT 75% SO THE HARD DRIVE WAS REPLACED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 THAT "EVERY OTHER TIME" THE PROGRAMMER WAS TURNED ON IT TOOK A LONG TIME, WITH "PLEASE WAIT" ERRORS. THESE ERRORS WOULD NOT GO AWAY UNTIL THE PROGRAMMER WAS RESTARTED, SOMETIMES MORE THAN ONCE. PER FOLLOW-UP, THE PROGRAMMER WAS CHANGED OUT AS THE WAIT TIMES WERE UNACCEPTABLE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "EVERY OTHER TIME" THE PROGRAMMER WAS TURNED ON IT TOOK A LONG LONG TIME, WITH "PLEASE WAIT" ERRORS. THESE ERRORS WOULD NOT GO AWAY UNTIL THE PROGRAMMER WAS RESTARTED, SOMETIMES MORE THAN ONCE. PER FOLLOW-UP, THE PROGRAMMER WAS CHANGED OUT AS THE WAIT TIMES WERE UNACCEPTABLE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469554 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 SOFTWARE ANALYZER| 229047 SOFTWARE ANALYZER