BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052906 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-13489
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-13490. IT WAS REPORTED THE PATIENT HAD DEVELOPED A FULL BODY RASH WHEN SHE HAD TURNED HER STIMULATION ON FOR THE FIRST TIME AFTER HER IMPLANT SURGERY. THE PATIENT¿S PHYSICIAN TREATED THE PATIENT WITH CORTISONE SHOTS. SEVERAL WEEKS LATER, THE PATIENT DEVELOPED ANOTHER FULL BODY RASH WHEN SHE HAD TURNED HER STIMULATION ON AGAIN. IT WAS NOTED WHEN THE PATIENT¿S STIMULATION IS OFF, SHE DOES NOT HAVE A RASH. FOLLOW-UP INFO IDENTIFIED THE PATIENT¿S PHYSICIAN OPTED TO REMOVE THE PT¿S ENTIRE SCS SYSTEM. ADD¿L FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135056 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3895944

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention