BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2251295 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-04192
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. THE PATIENT REPORTED HE HAD AN IPG LOW MESSAGE A MONTH BEFORE BUT WAS ABLE TO CHANGE PROGRAMS AND CONTINUE TO USE STIMULATION. THE PATIENT REPORTED THE STIMULATION STOPPED AND HE WAS UNABLE TO RESTART THE SYSTEM. THE PATIENT MET WITH THE SJM REPRESENTATIVE, AND IT WAS CONFIRMED THE IPG WAS DEPLETED. THE PATIENT WAS TO BE SCHEDULED FOR A REPLACEMENT PROCEDURE WITH HIS PHYSICIAN AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 2822110

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3289