BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950311 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-01398
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 3. REFER TO MFR REPORTS 1627487-2014-01399, 1627487-2014-01400. IT WAS REPORTED THAT THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT A YEAR AGO AT WHICH TIME HE NOTICED A REDUCTION IN STIMULATION. STIMULATION COULD BE FELT IN THE BUTTOCKS AND LEGS BUT NOT IN THE BACK OR FEET. IT WAS FURTHER REPORTED THAT THE IPG HAS BEEN UNABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER OR CHARGING SYSTEM FOR THE PAST 3 MONTHS AND THE PATIENT PROGRAMMER DISPLAYS A COMMUNICATION ERROR MESSAGE. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360758 EON MINI SCS IPG GZB ST JUDE MEDICAL NEUROMODULATION 3788 171786

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other