BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2181363 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-02892
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 22, 2011
    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 ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING STIMULATION COVERAGE IN THE AREAS WHERE SHE NEEDED IT. THE SYSTEM WAS EXPLANTED ON (B)(6) 2011. THE SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3269302

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SCS LEAD: MODEL 2 X 3186| IMPLANT: