BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110831 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02609
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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

    DEVICE 1 OF 3. REFERENCE MFR. REPORTS: 1627487-2013-02610 AND 1627487-2013-02611. THE PT HAS TWO SCS SYSTEMS (CERVICAL AND THORACIC). IT WAS REPORTED THE PT EXPERIENCED A HEATING SENSATION AND POSSIBLE BURN AT THER CERVICAL IPG SITE DURING CHARGING. SHE ALSO REPORTED A PERSISTENT PAIN AT THE CERVICAL IPG SITE THAT WAS NOT RELATED TO STIMULATION FOR CHARGING. SHE STATED THE SITE DISCOMFORT HAD OCCURRED SINCE APPROXIMATELY (B)(4) 2012. REPLACEMENT CHARGING SYSTEMS WERE SENT TO THE PT. IT IS UNDETERMINED WHICH OF THE PT'S CHARGER WAS INVOLVED WITH THE POCKET HEATING COMPLAINT; THEREFORE, BOTH OF THE PT'S CHARGERS ARE BEING REPORTED (DEVICE 2 AND DEVICE 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204853 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3389160

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3189 (2)| IMPLANT DATE: