BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2902997 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-13264
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 28, 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

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 INFO 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 PT DEVELOPED AN INFECTION AT THE IPG POCKET SITE. A CULTURE WAS TAKEN WHICH WAS POSITIVE. THE PT WAS TREATED WITH ANTIBIOTICS AND THE REPORTED INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 3560552

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)