BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3201758 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-15860
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    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 ADVISORY. 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

    IT WAS REPORTED THE PATIENT HAS BEEN WITHOUT STIMULATION FOR APPROXIMATELY 6 MONTHS AND IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. THE PATIENT INDICATED HE HAD NOT CHARGED HIS IPG SINCE THE LOSS OF STIMULATION OCCURRED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291358 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3410804

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other IMPLANT:| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3163| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT: