BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2950219 · Received February 6, 2013

    Report

    Report Number
    1627487-2013-05173
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 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
    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 PATIENT HAS BEEN EXPERIENCING DIFFICULTY RECHARGING THE IPG SINCE LOSING WEIGHT. IT SEEMS THE IPG HAS MOVED TO THE PATIENT¿S HIP AREA. THE PATIENT HAS DEACTIVATED STIMULATION DUE TO THE IPG BATTERY GETTING LOW. THE NEXT COURSE OF ACTION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50188 EON SCS IPG LGW ST. JUDE MEDICAL- NEUROMODULATION 3716 335926

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (X2| IMPLANT DATE:| SCS LEADS: MODEL 3186 (X2)