BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3111372 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-05665
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 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 HAS BEEN EXPERIENCING DISCOMFORT AT THE IPG SITE SINCE LOSING WEIGHT. THE PT EXPERIENCES THE DISCOMFORT WHEN SHE SLEEPS ON THE SIDE WHERE THE IPG IS LOCATED. THE PT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207403 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 97929

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCS LEAD: MODEL 3186 (X2)| SCS ANCHORS: MODEL 1192 (X2)| IMPLANTED:| IMPLANTED: