BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991364 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02153
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF A SHUT DOWN OR THAT THE PROGRAMMER WAS RUNNING SLOWLY, THE UNIT OPERATED CORRECTLY WITH RESPECT TO CONSISTENT POWER UP. ANALYSIS WAS ALSO UNABLE TO REPLICATE THE CUSTOMER COMMENT IN RESPECT TO A SYSTEM ERROR HOWEVER IT WAS CONFIRMED WITHIN THE LOGS AND THE HARD DRIVE WAS THEREFORE RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS DID FIND THE KEYBOARD SCREWS WERE MISSING HOWEVER THEY WERE LOCATED IN THE POWER SUPPLY, THAT THE PRINTER DRAWER WAS MISSING ITS PAPER GUIDE, THAT THE LEFT DISPLAY HASP WAS BROKEN, THAT THE LATCH TABS HAD BROKEN OFF OF THE CORD BAY DOOR AND THAT THE POWER SUPPLY FAN WAS NOISY. ALL FOUND DEFECTIVE PARTS WERE REPLACED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN IN THE MIDDLE OF A PACEMAKER CHECK AND THAT PRIOR TO THAT SHUTDOWN IT WAS RUNNING VERY SLOWLY. IT WAS FURTHER REPORTED THAT ON REBOOT THE PROGRAMMER CONTINUED TO RUN SLOWLY AND GENERATED AN ERROR MESSAGE. FOLLOW-UP CONFIRMED THAT FOLLOWING A REBOOT THE PROGRAMMER WAS ABLE TO COMPLETE THE DEVICE CHECK. THE PROGRAMMER WAS RETURNED FOR SERVICE AND IT WAS INDICATED THAT THERE WERE NO COMPLICATIONS TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN IN THE MIDDLE OF A PACEMAKER CHECK AND THAT PRIOR TO THAT SHUTDOWN IT WAS RUNNING VERY SLOWLY. IT WAS FURTHER REPORTED THAT ON REBOOT THE PROGRAMMER CONTINUED TO RUN SLOWLY AND GENERATED AN ERROR MESSAGE. FOLLOW-UP CONFIRMED THAT FOLLOWING A REBOOT THE PROGRAMMER WAS ABLE TO COMPLETE THE DEVICE CHECK. THE PROGRAMMER WAS RETURNED FOR SERVICE AND IT WAS INDICATED THAT THERE WERE NO COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469844 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD| 2067 RADIOFREQUENCY PROGRAMMER HEAD