BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110951 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-15605
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 16, 2013
    Report Date
    April 16, 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

    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. CONCLUSION: 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 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. REF MFR REPORT: 1627487-2013-15606. IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PT STATED SHE HAD BEEN HAVING COLD SWEATS FOR OVER A MONTH PRIOR TO THE EXPLANT AND ENDING ON (B)(6) 2013. ADDITIONALLY, DURING THAT TIME FRAME, SHE HAD BEEN PLACED ON ANTIBIOTICS TO TREAT A COLD SORE ON HER RIGHT EYE AND SUFFERED A FALL. THE PT STATED HER IMPLANT SITES WERE LEAKING FLUID AND HER PHYSICIAN PLACED A STERI STRIP OVER THE SITE. THE LEAKING CONTINUED AND THE PT STATED HER PHYSIC AN INDICATED AN INFECTION WAS PRESENT. CULTURES WERE TAKEN AND THE PHYSICIAN IS NOT AWARE WHAT, IF ANY GROWTH, WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202217 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3878689

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention