BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2131133 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00897
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER ANALYSIS OF THE EVENT PROMPTED A CHANGE IN THE CONCLUSION CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLIENT TRIES TO PRINT AN ICD REMOTE TRANSMISSION, GETS A MESSAGE THAT INDICATES THE PATIENT ALREADY HAS A ICD REMOTE AND TO CHOOSE ANOTHER DATE AND/OR TIME FOR THIS TEST BEFORE PROCEEDING. CLIENT GETS SAME MESSAGE WHEN TRYING TO SAVE OR CLOSE AS WELL. CLIENT HAD TO FORCE PACEART TO CLOSE WITHOUT SAVING THEIR WORK. A WORKAROUND WAS CREATED AND THE CLIENT WAS ADVISED HOW TO WORK AND SAVE DATA. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLIENT TRIES TO PRINT AN ICD REMOTE TRANSMISSION, GETS A MESSAGE THAT INDICATES THE PATIENT ALREADY HAS A ICD REMOTE AND TO CHOOSE ANOTHER DATE AND/OR TIME FOR THIS TEST BEFORE PROCEEDING. CLIENT GETS SAME MESSAGE WHEN TRYING TO SAVE OR CLOSE AS WELL. CLIENT HAD TO FORCE PACEART TO CLOSE WITHOUT SAVING THEIR WORK. A WORK AROUND WAS CREATED AND THE CLIENT WAS ADVISED HOW TO WORK AND SAVE DATA. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLIENT TRIES TO PRINT AN ICD REMOTE TRANSMISSION, GETS A MESSAGE THAT INDICATES THE PATIENT ALREADY HAS A ICD REMOTE AND TO CHOOSE ANOTHER DATE AND/OR TIME FOR THIS TEST BEFORE PROCEEDING. CLIENT GETS SAME MESSAGE WHEN TRYING TO SAVE OR CLOSE AS WELL. CLIENT HAD TO FORCE PACEART TO CLOSE WITHOUT SAVING THEIR WORK. A WORKAROUND WAS CREATED AND THE CLIENT WAS ADVISED HOW TO WORK AND SAVE DATA. 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. GCII ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other