BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3024659 · Received March 21, 2013

    Report

    Report Number
    1627487-2013-13414
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING PERSISTENT PAIN AT HER IPG SITE. IT WAS NOTED THE PT DOES NOT CURRENTLY HAVE STIMULATION, (REF. MFR REPORT 212947-201315097). IT WAS ALSO REPORTED THE PT WAS GOING TO CONSULT WITH HER PHYSICIAN FOR POSSIBLE RELOCATION OF HER IPG POCKET. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118156 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3139292

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3245