BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192064 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-01722
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT FOR "PATIENT DISCOMFORT" WAS NOT CONFIRMED. VISUAL INSPECTION OF THE RETURNED IPG DID NOT REVEAL ANY ANOMALIES THAT WOULD CONTRIBUTE TO THE COMPLAINT. THE IPG WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PT'S IPG IS PROTRUDING OUT CAUSING DISCOMFORT DUE TO WEIGHT LOSS. THE PT DOES NOT USE HER SCS SYSTEM ANY LONGER SINCE HER PAIN IS UNDER CONTROL. THE PT'S IPG SYSTEM WAS REMOVED AND HER LEADS WERE LEFT IMPLANTED FOR POSSIBLE FUTURE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281636 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3450404

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3245| SCS LEAD: MODEL 3163