BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3101901 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-08054
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 FELT TENDERNESS AND TEMPERATURE CHANGES AROUND THE IPG SITE BUT IT WAS SUSPECTED TO BE RELATED TO HER MUSCULAR DISEASE AND POST-SURGICAL PAIN. THE FOLLOWING DAY, THE PT HAD FEVER AND A REDNESS WAS OBSERVED AT THE IPG SITE. FOLLOW-UP INFORMATION SUGGESTED, THE PT WAS ON ANTIBIOTICS AND THE REDNESS AT THE IPG SITE CLEARED COMPLETELY. THE PT WAS DOING WELL WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196534 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3875418

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS LEAD: MODEL: 3286| SCS LEAD: MODEL: 3186| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL: 1192 (2)