BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2800858 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-01879
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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 EXPERIENCED RESPIRATORY PROBLEMS DURING THE PERMANENT IMPLANT AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PATIENT IS NOW DOING WELL AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 378914

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL (2)| IMPLANT DATE: