BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123486 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04608
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 WAS EXPERIENCING A PERSISTING PAIN AT THE IPG SITE WHICH EXTENDED TO THE TESTICULAR AREA. THE PT REPORTED, HE HAD DIFFICULTY WITH URINATION DUE TO THE ISSUE. THE PT WAS USING THE STIMULATION CONSTANTLY AND REPORTED EFFECTIVE STIMULATION RELIEF. THE PHYSICIAN REQUESTED FOR THE PT TO TURN THE SCS SYSTEM OFF AND ORDERED A CT SCAN TO BE PERFORMED TO DETERMINE IF THE IPG WAS IRRITATING A NERVE. FOLLOW-UP ON THE PT STATUS IDENTIFIED THE PT DID RECEIVE A CT SCAN. IT WAS REPORTED THE PT HAD A DISC EXTRUSION IN THE SACRAL AREA. IT WAS REPORTED THIS ISSUE WAS UNRELATED TO THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219328 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3525154

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD, MODEL 3225| IMPLANT DATE: