BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2131061 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00894
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 19, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CORRECTION: 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. FURTHER ANALYSIS OF THE EVENT PROMPTED A CHANGE IN THE CONCLUSION CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEART SYSTEM SESSION SYNC STOPPED WORKING AFTER AN UPGRADE TO THE COMPUTER'S ANTIVIRUS SOFTWARE. THE PRODUCT REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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. GC 3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other