BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3231568 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-03967
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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 # 1627487-2013-03968. IT WAS REPORTED THE PT IS EXPERIENCING HIS SCS IPG HEATING WHILE CHARGING. SUBSEQUENTLY, THE PT REC'D A LOW ENERGY REPLACEMENT CHARGING SYS TO ADDRESS THE ISSUE. IT WAS ALSO REPORTED THE PT'S SCS IPG IS TURNING OFF AND ON BY ITSELF AND IS SOMETIMES NON-FUNCTIONAL. 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
    322107 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3558585

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)