BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903153 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-10001
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ST. JUDE MEDICLA - 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 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 WAS UNABLE TO ESTABLISH COMMINATION BETWEEN HER SCS IPG AND THE EXTERNAL DEVICES (PT PROGRAMMER AND CHARGING SYSTEM). SUBSEQUENTLY, THE PT IS WITHOUT STIMULATION. IN ADDITION, THE PT REPORTED, SHE HAS LOST WEIGHT STATING, THE IPG HAS SUNKEN INTO HER LEFT BUTTOCK. WEN PRESSURE IS APPLIED TO THE IPG SITE, THE IPG MOVES FURTHER FROM THE SURFACE. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343 EON MINI SCS IPG LGW ST. JUDE MEDICLA - NEUROMODULATION 3788 3504711

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219