BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052596 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-15452
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2012
    Report Date
    March 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 A BURNING SENSATION AROUND THE IPG SITE. THE SENSATION OCCURS REGARDLESS OF STIMULATION BUT IS NOT RELATED TO CHARGING. THE SJM REPRESENTATIVE ADVISED THE PATIENT TO TURN STIMULATION OFF. THE PATIENT IS TO CONSULT WITH HER PHYSICIAN AND HAVE X-RAYS TAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135638 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3157565

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194