BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110614 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-06276
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND 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: 1627487-2013-06277. IT WAS REPORTED THE PATIENT IS EXPERIENCING POCKET HEATING WHILE CHARGING HIS IPG. THE PATIENT STATED HIS IPG POCKET SITE GETS RED WHEN HE CHARGES. THE PATIENT STOPPED USING AND CHARGING THE SYSTEM FOR ABOUT TWO MONTHS. THE PATIENT ALSO REPORTED ACCUMULATION OF FLUID AND THE IPG IS MOVING INSIDE THE POCKET. A NEW LOW ENERGY CHARGER WAS SENT TO ADDRESS THE HEATING ISSUE AND THE PATIENT WAS ADVISED TO CONTACT HIS PHYSICIAN TO EXAMINE THE IPG POCKET SITE. THE PATIENT IS PENDING FOLLOW UP WITH AN SJM REPRESENTATIVE. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208705 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3540056

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: