BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3133058 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-06322
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 PATIENT'S IPG WAS REPLACED. THE REASON FOR THE REPLACEMENT IS UNKNOWN. THE IPG WAS REPLACED WITH A DIFFERENT MODEL AND THE IPG POCKET WAS MOVED FROM THE CHEST AREA TO THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223294 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3359256

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3383 (X2)| SCS LEAD, MODEL 3146 (X2)| SCS LEAD, MODEL 3149| IMPLANT DATE:| IMPLANT DATE: