BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3192046 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-15836
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE. THE PATIENT STATED THE IPG DID NOT SIT RIGHT AND WAS PROTRUDING FROM HER BACK CAUSING THE DISCOMFORT. THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. THE PATIENT STATED THE REPLACEMENT IPG RESOLVED THE ISSUE AND SHE NO LONGER HAS DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281027 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3591543

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS LEAD, MODEL 3228| IMPLANT DATE: