BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791510 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03320
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 26, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4): THE PROGRAMMER WAS RETURNED AND IT WAS NOTED UPON INCOMING INSPECTION THAT A HARDWARE UPDATE WAS REQUIRED. ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT START UP. ANALYSIS ALSO FOUND THAT THE STYLUS CABLE WAS DAMAGED, THERE WAS NO PAPER IN THE PRINTER, THE SILICONE LAYER OF THE RADIO FREQUENCY HEAD WAS MISSING, THE POWER BAY WAS DEFECTIVE, THE FAN WAS NOISY AND THE KEYBOARD HINGES DEFECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT START. THE PROGRAMMER WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT INDICATED. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED AND ANALYZED AND TESTED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT START. THE PROGRAMMER WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other