BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3954939 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-06203
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    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 THREE FIELD ADVISORIES. 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 THAT THE PATIENT WAS EXPERIENCING PAIN IN HIS IPG SITE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE HIS IPG POCKET WAS RELOCATED. THE PHYSICIAN ALSO DECIDED TO ELECTIVELY REPLACE THE IPG WITH A NEW ONE DUE TO THE AGE OF THE IPG. THERE IS NO KNOWN ISSUE WITH THE IPG AND IT WAS FUNCTIONING PROPERLY. THE PATIENT'S ISSUE IS NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415911 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 174962

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS LEAD: MODEL 3228,| IMPLANT DATE: