BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2131047 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00890
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 21, 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. 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

    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 STARTED THE REMOTE SUPPORT SESSION, THERE WAS AN ERROR DURING IMPORT OF EVENT DATA AND SEVERAL ERROR LOGS. IT APPEARED THAT THE PROGRAMMER WAS "SYNCING" BUT NOTHING WAS COMING INTO PACEART. THE PRODUCT REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLINICIAN STARTED THE REMOTE SUPPORT SESSION, THERE WAS AN ERROR DURING IMPORT OF EVENT DATA AND SEVERAL ERROR LOGS. IT APPEARED THAT THE PROGRAMMER WAS "SYNCING" BUT NOTHING WAS COMING INTO PACEART. 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. GCII ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other