BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110750 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-03630
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03631. THE PATIENT REPORTED EXPERIENCING UNCOMFORTABLE HEATING AT HER SCS IPG POCKET SITE THE DAY AFTER CHARGING. THE PATIENT ALSO REPORTED SHE USED AN ICE PACK TO ALLEVIATE THE ISSUE. ADDITIONALLY, A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. FOLLOW-UP IDENTIFIED THE PATIENT HAS NOT EXPERIENCED HEATING WHILE CHARGING; HOWEVER, SHE EXPERIENCED BURNING AT HER SCS IPG POCKET SITE WHILE USING SYSTEM STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202617 EON MINI SCS IPG LGW ST. JUDE MEDICAL- NEUROMODULATION 3788 3776223

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: