BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2850068 · Received November 26, 2012

    Report

    Report Number
    1627487-2012-06801
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 5, 2008
    Report Date
    October 30, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2012-06802. IT WAS REPORTED, THE PATIENT EXPERIENCED OVERSTIMULATION WHILE BEING PROGRAMMED POST-OP. AS A RESULT, THE PATIENT HAS NOT USED THE SCS SYSTEM SINCE. IT WAS ALSO REPORTED, THE PATIENT IS EXPERIENCING PAIN AT THE IPG SITE. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 173687

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention