BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791727 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03291
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: THE PROGRAMMER WAS RETURNED AND ANALYZED, AND UPON INCOMING INSPECTION THE TOUCH-SCREEN CALIBRATION WAS DETERMINED TO BE OUT OF RANGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A "CONFUSING REACTION OF THE CURSOR TO THE TOUCH PEN ON THE SCREEN." TROUBLESHOOTING ATTEMPTS INCLUDING DEMO PROGRAMS, PACER DEVICES, CALIBRATION, AND CHANGING THE TOUCH PEN, WERE UNSUCCESSFUL. THE PROGRAMMER WAS REPLACED AND RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 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 HAD A "CONFUSING REACTION OF THE CURSOR TO THE TOUCH PEN ON THE SCREEN." TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL. THE PROGRAMMER WAS REPLACED AND RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 79 YR Other