BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950293 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-01403
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    IT WAS REPORTED THE PATIENT PRESENTED TO THE ER WITH BACK MUSCLE SPASMS ON (B)(6) 2014. THE PATIENT WAS INITIALLY IMPLANTED FOR RIGHT SIDED INGUINAL PAIN. FOLLOW-UP IDENTIFIED THE PATIENT WAS SEEN BY HER PHYSICIAN ON (B)(6) 2014 EXPERIENCING PERSISTENT PAIN AT THE IPG SITE. THE PATIENT STATED THE CURRENT LOCATION OF THE IPG CAUSES DISCOMFORT TO HER BACK AND RIBS WHEN SITTING. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE TO REPOSITION THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360760 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4486899

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219