BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926336 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-15426
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-15427. IT WAS REPORTED THE PATIENT'S CHARGING SYSTEM WAS UNABLE TO LOCATE HER IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND INDICATED NEITHER THE REPLACEMENT CHARGING SYSTEM AND PATIENT PROGRAMMER WERE UNABLE TO COMMUNICATE WITH OR CHARGE THE IPG. THE PROGRAMMER DISPLAYED A COMMUNICATION ERROR. THE PATIENT LAST CHARGED HER IPG APPROXIMATELY 1.5 MONTHS AGO AND IS CURRENTLY WITHOUT STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE. THE PATIENT HAS 2 SCS SYSTEMS IMPLANTED. IT IS UNKNOWN WHICH IPG IS ASSOCIATED WITH THE ISSUE; THEREFORE, BOTH IPGS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322057 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4172291

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS LEAD: MODEL 3186 (4)| IMPLANT DATE: