BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860019 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01538
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID: 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER'S SCREEN FROZE UP AND DETERMINED THAT THE PROGRAMMER HAD AN ERROR AFTER BEING LEFT ON FOR OVER HALF AN HOUR WITH THE IMPLANTABLE SOFTWARE LOADED, AND THEREFORE THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. CONCOMITANT PRODUCT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN FROZE UP WHEN LEFT ON WITH THE IMPLANTABLE DEVICE INFORMATION LOADED, AND THAT THE DEVICE WAS UNABLE TO PROGRAM WITH THE PEN OR THE RADIOFREQUENCY PROGRAMMER HEAD. THE POWER WAS TURNED OFF AND THEN BACK ON AND THE INFORMATION WAS RETAINED. THE PROGRAMMER HAD BEEN ON FOR 20-30 MINUTES PRIOR TO THE OCCURRENCE AND IT OCCURRED THREE TIMES IN A ROW. 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 THE PROGRAMMER'S SCREEN FROZE UP WHEN LEFT ON WITH THE IMPLANTABLE DEVICE INFORMATION LOADED, AND THAT THE DEVICE WAS UNABLE TO PROGRAM WITH THE PEN OR THE RADIOFREQUENCY PROGRAMMER HEAD. THE POWER WAS TURNED OFF AND THEN BACK ON AND THE INFORMATION WAS RETAINED. THE PROGRAMMER HAD BEEN ON FOR 20-30 MINUTES PRIOR TO THE OCCURRENCE AND IT OCCURRED THREE TIMES IN A ROW. 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
    340204 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 R2067 RADIOFREQUENCY PROGRAMMER HEAD| R2067 RADIOFREQUENCY PROGRAMMER HEAD