BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2131209 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00933
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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. FURTHER ANALYSIS OF THE EVENT PROMPTED A CHANGE IN THE CONCLUSION CODE.

    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. FURTHER ANALYSIS OF THE EVENT PROMPTED A CHANGE IN THE CONCLUSION CODE. CORRECTION NOTE: THIS COMPLAINT WAS INADVERTENTLY SUBMITTED UNDER THE MEDICAL DEVICE REPORTING REGULATIONS, AS THE POTENTIAL FOR INJURY IS NOT LIKELY FOR THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A TRANSMISSION COULD NOT BE FOUND ON THE NETWORK. THE TEST WAS DOWNLOADED AGAIN AND MANUALLY MATCHED TO THE CORRECT PATIENT. THE NETWORK REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A TRANSMISSION COULD NOT BE FOUND ON THE NETWORK. THE TEST WAS DOWNLOADED AGAIN AND MANUALLY MATCHED TO THE CORRECT PATIENT. THE NETWORK REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEART SYSTEM SOFTWARE DPS MEDTRONIC, INC. GCIII ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other