BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2930529 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-03158
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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

    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03159. IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN NEAR HER SCS LEAD SITE IN ADDITION TO TENDERNESS AT HER SCS LEAD SITE AND SCS IPG POCKET SITE. IT WAS ALSO REPORTED THE PATIENT IS EXPERIENCING A PULLING SENSATION WITH AND WITHOUT SYSTEM STIMULATION. FOLLOW-UP IDENTIFIED A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. THE PATIENT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33989 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3706481

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention