BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 2291789 · Received October 13, 2011

    Report

    Report Number
    2182208-2011-02240
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    May 6, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. CORRECTED DATA: THE SUSPECT MEDICAL DEVICE WAS INADVERTENTLY REPORTED FOR THIS COMPLAINT UNDER MANUFACTURING REPORT NUMBER 2182208-000-2011-02240 AND AS A RESULT THIS REPORT IS BEING REDACTED. THE EVENT INVOLVES UNVIEWABLE TRANSMISSIONS, HOWEVER, THERE IS NO IMPACT TO CLINICAL DATA AND THE POTENTIAL FOR INJURY IS REMOTE. THEREFORE, A CORRECTION WITH REDACTION REQUEST IS BEING SUBMITTED ACCORDINGLY. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLINICIAN LOGGED INTO CARELINK TO VIEW PATIENT TRANSMISSION THEY WERE NOT ALL VIEWABLE. A COUPLE DAYS LATER WHEN THE CLINICIAN LOGGED IN THEY WERE AVAILABLE. TWO SERIAL NUMBERS WERE VERIFIED AND HAD COMPLETED ON THE EXPECTED DATE. IT WAS UNABLE TO BE DETERMINED WHY THE TRANSMISSIONS WERE NOT VISIBLE TO THE CLINICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLINICIAN LOGGED INTO CARELINK TO VIEW PATIENT TRANSMISSION THEY WERE NOT ALL VIEWABLE. A COUPLE DAYS LATER WHEN THE CLINICIAN LOGGED IN THEY WERE AVAILABLE. TRANSMISSIONS WERE VERIFIED AND HAD COMPLETED ON THE EXPECTED DATE. FURTHER INVESTIGATION BY TECHNICAL SERVICES INDICATED THAT THE TIME OF THE TRANSMISSION CLOSELY CORRELATES TO THAT OF THE DEVICE INTERROGATION TIME, INDICATING THERE WAS NO DELAY IN PROCESSING THE TRANSMISSIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK SYSTEM SOFTWARE DXY MEDTRONIC, INC. CARELINK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other