BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022405 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-01337
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 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. CONCLUSIONS - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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: 1627487-2013-01338. IT WAS REPORTED THE PT HAS AN INFECTION AT HER IPG SITE. WOUND BREAKDOWN AND EXCESSIVE DRAINAGE AT LOWER MEDIAL EDGE OF IPG SITE WAS NOTED. CULTURES WERE TAKEN AND THE IPG SITE WAS WASHED OUT ON (B)(6) 2013. A DRAIN WAS PUT IN PLACE AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. FOLLOW UP INFO IDENTIFIED THE CULTURES RESULTS WERE (B)(6) FOR (B)(6). THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119985 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3875430

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R