BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3925949 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-23401
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN THE IPG AND THE PT PROGRAMMER. IT IS UNK IF THE CHARGER WAS UNABLE TO COMMUNICATE WITH THE IPG. IT WAS ALSO REPORTED THE PT HAS NOT CHARGED HER IPG IN APPROXIMATELY 2 YEARS. THE PT IS WITHOUT STIMULATION. F/U INFO REVEALED THE PT WILL UNDERGO SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349121 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 174915

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other MODEL 3166 (2)| IMPLANT DATE:| MODEL 3343 (2)| IMPLANT DATE: