BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2162029 · Received July 12, 2011

    Report

    Report Number
    1627487-2011-01726
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    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. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A BURNING SENSATION AT THE IPG SITE. SHE STATED THAT SHE FEELS THE SENSATION WHEN HER STIMULATION IS ON AND OFF, AND THE SENSATION IS UNRELATED TO CHARGING THE IPG. SHE STATED SHE CURRENTLY HAS THE STIMULATION TURNED OFF. THE PATIENT REPORTED THAT SHE FELL ON THE IPG SITE THREE MONTHS AGO. THE PATIENT PLANS TO FOLLOW UP WITH HER PHYSICIAN REGARDING THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3166011

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R IMPLANT:| SCS LEAD: MODEL 3228