BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2926074 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-03130
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 PT'S SCS IPG WAS EXPLANTED DUE TO THE PT EXPERIENCING NUMBNESS IN HIS LEGS. THE PT'S SCS LEADS REMAIN IMPLANTED. F/U IDENTIFIED THERE IS NO PLAN TO HAVE THE SCS IPG REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25401 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 2824302

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS LEAD: MODEL 3189 (2)| IMPLANT: