BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4203311 · Received October 23, 2014

    Report

    Report Number
    1627487-2014-26883
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    November 1, 2013
    Report Date
    October 3, 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 HAD NOT USED HIS STIMULATION OR RECHARGED HIS IPG FOR APPROXIMATELY ONE YEAR. THE PATIENT REPORTS MEDICATION WAS RELIEVING HIS PAIN AND HE STOPPED USING HIS SCS SYSTEM. THE PATIENT ATTEMPTED TO USE HIS SCS SYSTEM, HOWEVER THE STIMULATION WAS OFF AND THE IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677457 EON SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 46205A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS EXTENSION: MODEL 3314| IMPLANT:| IMPLANT:| SCS EXTENSION: MODEL 3383| IMPLANT:| SCS EXTENSION: MODEL 3383 (2)| IMPLANT:| SCS EXTENSION: MODEL 3343| IMPLANT:| SCS LEAD: MODEL 3156 (2)| SCS LEAD: MODEL 3245