BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3141937 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-12728
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 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

    THE DEVICE WAS EXPLANTED DUE TO DISCOMFORT AT THE IPG SITE DUE TO THE SIZE OF THE IPG. THERE IS NO ALLEGED DEVICE FAILURE TO MEET SPECIFICATION. THE EVENT CANNOT BE CONFIRMED THROUGH PRODUCT ANALYSIS TESTING, THEREFORE NO CHECKLIST WAS INITIATED (B)(4). DHR REVIEW HAS NO IMPACT ON THIS COMPLAINT HENCE NONE REQUESTED. 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 EXPERIENCES DISCOMFORT DUE TO THE SIZE OF THE IPG. THE IPG WAS EXPLANTED AND REPLACED WITH A SMALLER IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233415 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3818506

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS LEAD: MODEL 3166 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE: