BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 2130654 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-02818
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010 FOR LOW BACK AND BILATERAL HIP, LEG AND FOOT PAIN. IT WAS REPORTED THAT THE PATIENT'S ANKLES BECAME SWOLLEN AND SHE FEELS PAIN IN BOTH LEGS WHEN THE STIMULATOR IS ON. THE PATIENT STATED THAT THESE SYMPTOMS TAKE A WHILE TO DISSIPATE AFTER SHE TURNS OFF THE STIMULATION. X-RAYS SHOWED NO ANOMALIES. FOLLOW UP ON THE PATIENT (B)(6) 2011 FOUND THAT THE PHYSICIAN PLANS TO EXPLANT THE PATIENT'S SCS SYSTEM; HOWEVER, THE EXPLANT DATE IS CURRENTLY UNDETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3101642

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ANCHOR: MODEL 2 X 1192| SCS LEAD: MODEL 2 X 3186| IMPLANTED:| IMPLANTED: