BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091859 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-02599
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    May 9, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS WITHOUT STIMULATION THERAPY AND IS UNABLE TO COMMUNICATE WITH HER IPG AND EXTERNAL DEVICES. THE PATIENT STATED SHE HAS NOT USED OR CHARGED HER SCS IPG IN SEVERAL MONTHS. THE PATIENT STATED HER PATIENT PROGRAMMER DISPLAYS A COMMUNICATION ERROR. THE PATIENT IS PENDING A FOLLOW-UP WITH A SJM REPRESENTATIVE TO FURTHER EVALUATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526125 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3610102

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: