BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2210699 · Received August 8, 2011

    Report

    Report Number
    1627487-2011-03399
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAD A DERMATOLOGIST REMOVE A CYST ON HER BACK. ELECTROCAUTERY WAS USED IN THE MIDDLE OF THE BACK ABOUT AN INCH FROM HER POCKET INCISION. WHEN THE PROCEDURE WAS PERFORMED, THE PT FELT A STRONG SENSATION THROUGHOUT HER BODY LIKE BEING STABBED. SINCE THEN, THE PT FEELS TINGLING IN HER LOWER HALF WHEN THE STIMULATION IS ON. THE PT WAS INSTRUCTED TO NOTIFY HER IMPLANTING PHYSICIAN. NO FURTHER INFO 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 3319728

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3219