BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3101960 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-06250
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 11, 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 STILL EXPERIENCING SURGICAL PAIN AT THE POCKET SITE TWO MONTHS AFTER THE IMPLANT. THERE IS NO EVIDENCE OF INFECTION AND THE PT IS RECEIVING EFFECTIVE STIMULATION. THE PHYSICIAN HAS PRESCRIBED MEDICATION AND INSTRUCTED THE PT TO TREAT THE POCKET SITE WITH ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197149 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3818174

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD: MODEL: 3186 (X2)| IMPLANT DATE: