BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2790282 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03380
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 27, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    THE CUSTOMER'S INFORMATION TECHNOLOGY (IT) STATED THAT THE PATIENT CALLED IN A COMPETITOR ARRHYTHMIA TRANSTELEPHONIC MONITOR (TTM) AND IT SEEMED LIKE THE STRIP RECORDED NORMALLY. AFTER SAVING THE EVENT THE NURSE WENT BACK TO PARSE THE EVENTS AND THE ELECTROCARDIOGRAM (ECG) LOOKS ALMOST LIKE A FLAT LINE. INVESTIGATION SHOWED THAT THE SAME DATA RECORDED IN THE ELECTRONIC MEDICAL RECORD THE CARDIOGRAM LOOKS THE SAME IN THAT APPLICATION AS WELL. IT WAS SUGGESTED THAT THE CUSTOMER TROUBLESHOOT THE COMPETITOR ARRHYTHMIA MONITOR BECAUSE OTHER CARDIOGRAMS RECORDED BEFORE AND SINCE (FOR OTHER PATIENTS AS WELL) ARE NORMAL IN THE APPLICATION. IT COULD NOT BE DEFINITIVELY DETERMINED WHETHER THE ISSUE WAS THE RESULT OF THE APPLICATION OR THE COMPETITOR MONITOR. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other