BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2970983 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-03234
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS EXPERIENCING DISCOMFORT AT HIS SCS IPG POCKET SITE. SUBSEQUENTLY, SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE. FOLLOW-UP IDENTIFIED THE PT WAS ILL AT THE TIME OF THE SCHEDULED INTERVENTION. SUBSEQUENTLY, THE PROCEDURE WAS CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69499 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3610102

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS LEAD: MODEL: 3228| IMPLANT DATE: