BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C

    MDR report key: 3150074 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-04658
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 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 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

    IT WAS REPORTED THE PT HAD PAIN AT THE IPG SITE AND THE PHYSICIAN PLANNED TO MOVE THE IPG TO A NEW POCKET SITE. F/U IDENTIFIED THE PHYSICIAN OPTED TO REPLACE THE IPG AND PLACED THE DEVICE IN A NEW LOCATION TO ADDRESS THE DISCOMFORT. THE PT WAS RECEIVING STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237678 EON C SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3783324

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3228| IMPLANT:| SCS ANCHOR: MODEL 1194 (2)