BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110819 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-15607
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2010
    Report Date
    April 18, 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
    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 PT HAS NOT USED OR CHARGED HER IPG IN APPROXIMATELY 3 YEARS. THE PT INDICATED SHE HAS NOT NEEDED TO USE HER SCS SYSTEM BECAUSE SHE WAS NOT IN PAIN, HOWEVER, HER PAIN HAS NOW RETURNED. THE SJM REP MET WITH THE PT AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE THE IPG. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204744 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 174329

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3189