BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4212909 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-12717
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND 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 EXPERIENCES INEFFECTIVE STIMULATION. THE PATIENT HAS NOT CHARGED OR USED THE SCS SYSTEM FOR OVER EIGHT MONTHS. THE IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678883 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 3549332

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other IMPLANT DATE:| SCS LEADS: MODEL 3186(2)