BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2993982 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-05285
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 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

    EVAL 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 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 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

    IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO A STAPH INFECTION AT THE IPG SITE. THE PATIENT IS DOING WELL AND THE INFECTION HAS RESOLVED. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89282 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3755776

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3169| EXPLANT:| EXPLANT:| EXPLANT:| IMPLANT:| SCS LEAD: MODEL 3246 (X2)| IMPLANT:| IMPLANT:| EXPLANT:| SCS EXTENSION: MODEL 3246| SCS ANCHORS: MODEL 1192 (X3)