BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052309 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-01396
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 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 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

    IT WAS REPORTED THE PT IS EXPERIENCING PAIN AND SORENESS AT HER IPG SITE. THE PT STATED THAT THE IPG FELT AS IF IT HAD FLIPPED OVER IN THE POCKET. SHE APPLIED PRESSURE TO IT AND FLIPPED THE IPG BACK OVER. X-RAYS WERE TAKEN AND DID NOT SHOW ANY ABNORMALITIES. THE PT IS RECEIVING EFFECTIVE STIMULATION AND HAS NO ISSUES WITH CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137602 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3584301

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS LEAD: MODEL: 3186 (2)| IMPLANT DATE: