BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032015 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-12400
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2013-12401. IT WAS REPORTED, THE PATIENT EXPERIENCES HEATING AT THE IPG POCKET SITE WITH STIMULATION ON, AND THE POCKET SITE GETS WARMER WHEN CHARGING. THE AREA IS ALSO SWOLLEN. A NEW CHARGER WAS SENT TO THE PATIENT. REPORTEDLY, THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122966 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3553141

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS ANCHORS: MODEL 1192 (3)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3166| SCS LEAD: MODEL 3163| SCS LEAD: MODEL 3244| IMPLANT DATE: