BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2970951 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-05212
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2012
    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
    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#: 1627487-2013-05213. IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING HEATING AT THE IPG SITE WHILE RECHARTERING SINCE BEING IMPLANTED. IT WAS ALSO REPORTED THE PATIENT EXPERIENCES PAINFUL OVERSTIMULATION AT THE IPG SITE ONCE A WEEK. THE PATIENT WAS SENT A REPLACEMENT CHARGING SYSTEM TO ADDRESS THE POCKET HEATING ISSUE. ON (B)(4) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENT RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENT AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69567 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3535799

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT:| SCS LEAD: MODEL - 3288