BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2772003 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-12200
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    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

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. SJM HAS LIMITED INFO 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12201. THE PT REPORTED A CLEAR DISCHARGE NEAR THE IPG SITE. PT DOES NOT HAVE A FEVER, HOWEVER THE IPG SITE IS SENSITIVE TO THE TOUCH. ON (B)(6) 2012 THE PT SAW THE IMPLANTING PHYSICIAN. REPORTEDLY THE INCISION WAS EXAMINED AND A CULTURE WAS TAKEN. PT WAS GIVEN ORAL ANTIBIOTICS AND SCHEDULED FOR AN EXPLANT. ON (B)(6) 2012 THE IPG, LEADS AND ANCHORS WERE EXPLANTED. ON (B)(6) 2012, THE PT REPORTED SHE IS HEALING WELL, BUT WILL NOT HAVE ANOTHER SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3755951

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS ANCHOR: MODEL 1192(2)| IMPLANT: