BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2531679 · Received April 12, 2012

    Report

    Report Number
    2182208-2012-01349
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    February 10, 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.

    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. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED AT START OF FOLLOW-UP THE PROGRAMMER SOFTWARE CRASHED DURING SWITCH FROM MEDTRONIC TO VITATRON DESKTOP WITH AN ERROR MESSAGE. THE PROGRAMMER COULD NOT BE RESTARTED BY SWITCH OFF/ON. FOR THIS PROGRAMMER THE ACTUAL SOFTWARE UPDATE WAS NOT INSTALLED. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED AT START OF FOLLOW-UP THE PROGRAMMER SOFTWARE CRASHED DURING SWITCH FROM MEDTRONIC TO VITATRON DESKTOP WITH AN ERROR MESSAGE. THE PROGRAMMER COULD NOT BE RESTARTED BY SWITCH OFF/ON. FOR THIS PROGRAMMER THE ACTUAL SOFTWARE UPDATE WAS NOT INSTALLED. THE PROGRAMMER IS BEING RETURNED FOR SERVICE. 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 Other