BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2133434 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-00821
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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 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 SYS INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT'S IPG WAS CAUSING DISCOMFORT DUE TO ITS SIZE. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE DEVICE WITH A SMALLER MODEL AND EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 2762420

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT: