BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2993984 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10071
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 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
    JA
    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

    IT WAS REPORTED THE PATIENT ((B)(6)) IS EXPERIENCING DISCOMFORT AND A STRANGE FEELING AT THE IPG POCKET SITE WHILE STIMULATION IS ON. IT WAS NOTED THE PHYSICIAN SUSPECTS THE ELECTRIC BLANKET USED BY THE PATIENT COULD BE ONE OF THE REASONS THIS ISSUE IS OCCURRING. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88756 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention