BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052219 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-04411
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 13, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES AND A FIELD CORRECTION. THIS MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2013-04412. IT WAS REPORTED THAT PT WAS EXPERIENCING A PAINFUL BURNING SENSATION WHEN USING THE CHARGING SYSTEM TO CHARGE THE IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139697 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3203838

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)