BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2971788 · Received February 12, 2013

    Report

    Report Number
    1627487-2013-13204
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 WAS HAVING DIFFICULTY CHARGING AND COMMUNICATING WITH HER IPG. THE PT DID NOT LOSE STIMULATION COVERAGE; HOWEVER, IT WAS NOTED THE PT'S IPG WAS NOT LYING FLAT IN THE POCKET. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62014 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3775983

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3228