BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2133567 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00834
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT ALTHOUGH SHE HAS STIMULATION, SHE HAS EXPERIENCED LEG SWELLING AND THROBBING PAIN FROM HER HIPS DOWNWARD AND ACROSS HER BACK. THE PT HAS CONSULTED WITH HER PRIMARY CARE PHYSICIAN AND SEVERAL MEDICAL SPECIALIST INCLUDING HER IMPLANTING PHYSICIAN AND HAS UNDERGONE A BATTERY OF TESTS; HOWEVER, THE CAUSE OF THESE SYSTEMS REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2802316

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SCS LEAD EXTENSIONS: MODEL 3386| SCS LEADS: MODEL 3244| IMPLANTED:| IMPLANTED: