BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950227 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-01336
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 PT EXPERIENCES PAIN AT THE IPG SITE WITH STIMULATION INITIATED FOR ONE LEAD. REPROGRAMMING WAS PERFORMED UTILIZING THE OPPOSITE LEAD ONLY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014, TO REVISE THE IPG AS THE DEVICE REPORTEDLY SHIFTED MIDLINE. THE PROCEDURE WAS COMPLETED BY SUTURING THE IPG INTO THE ORIGINAL POCKET. FOLLOW-UP REVEALED THE ISSUE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376850 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3240701

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SCS LEAD: MODEL 3151| IMPLANT DATE: