BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2926109 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-15080
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 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

    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 WAS EXPERIENCING PAIN AT HER IPG SITE. THE IPG POCKET WAS REVISED IN ORDER TO PLACE THE IPG DEEPER. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25870 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3735160

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: