BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110794 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02630
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02631. THE PATIENT HAS TWO SCS SYSTEMS. IT WAS REPORTED THE PATIENT COMPLAINED OF INTENSE PAIN IN THE AREA OF HIS ABDOMINAL IPG POCKET SITE. IT WAS ALSO REPORTED THE PATIENT HAD PAIN ALONG THE LEAD TRACK. THE SURGEON RELOCATED THE IPG POCKET AND REPLACED THE IPG WITH A SMALLER MODEL ON (B)(6) 2013. FOLLOW-UP INDICATED THE PATIENT'S HAD EFFECTIVE STIMULATION COVERAGE AND RESOLUTION OF PAIN IN THE ABDOMEN. THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202710 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3625035

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS LEAD, MODEL 3149| IMPLANT DATE:| SCS LEAD, MODEL 3146 (2)| IMPLANT DATE:| SCS EXTENSION, MODEL 3386 (2)