BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850678 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-02353
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 18, 2014
    Report Date
    February 12, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. 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

    IT WAS REPORTED THE PATIENT'S THORACIC SCS SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S PHYSICIAN OBSERVED AN ABSCESS IN THE PATIENT'S LOW BACK, NEAR THE IPG. CULTURES WERE TAKEN AND THE PATIENT WAS TREATED WITH BOTH IV AND ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304049 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3145874

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (X2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (X2)