BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2970994 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-01172
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL 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: 1627487-2013-1175. IT WAS REPORTED THE PATIENT'S IPG IS VERY CLOSE TO HER SKIN, AND IT CAUSES HER SOME DISCOMFORT. HER PHYSICIAN STATED THE PATIENT HAS A POCKET AREA NEAR THE IPG THAT IS CAUSING THE PAIN AND IT WILL TAKE SOME TIME TO COMPLETELY HEAL FROM THE PROCEDURE. THE PATIENT WAS TREATED WITH PAIN MEDICATION AND WILL FOLLOW-UP WITH HER PHYSICIAN IN (B)(6) 2013. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A HEATING SENSATION WHILE CHARGING HER IPG. THE HEATING ISSUE WAS RESOLVED BY REPLACING HER CHARGER WITH A NEW LE CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69446 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3822411

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)