BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3082273 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-04453
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 UNDERGONE A BACK SURGERY AND HAD BEEN UNABLE TO COMMUNICATE WITH HER IPG SINCE THAT TIME. IN ADDITION, THE PATIENT NO LONGER HAD STIMULATION. A REPLACEMENT CHARGING SYSTEM WAS UNABLE TO COMMUNICATE WITH THE IPG. FOLLOW UP IDENTIFIED THE PHYSICIAN REPLACED THE IPG. IT WAS REPORTED THE PATIENT RECEIVED STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164147 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 118205

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention