BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792180 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-03511
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 18, 2012
    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
    TX, 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: 1627487-2012-03512. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SHARP/BURNING PAIN AT HIS SCS IPG POCKET SITE WHILE CHARGING HIS SCS SYSTEM. IT WAS ALSO REPORTED THE PATIENT EXPERIENCES TENDERNESS AT HIS SCS IPG POCKET SITE WHEN HE USES SYSTEM STIMULATION FOR SEVERAL HOURS WHICH AFTERWARDS CAUSES DISCOMFORT WHEN THE PATIENT LEANS AGAINST OBJECTS. A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUES WITH REPROGRAMMING. FOLLOW-UP IS PENDING. ON (B)(6) 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
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3527439

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228| SCS LEAD: MODEL 3383 (2)| IMPLANT DATE: