BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961148 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-03469
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD CORRECTION: 1627487-07262012-002-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

    IT WAS REPORTED THE PATIENT HAS NOT USED/CHARGED HER SCS SYSTEM IN APPROXIMATELY ONE YEAR AND IS UNABLE TO INITIATE STIMULATION. IT WAS ALSO REPORTED THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND EXTERNAL DEVICES AND HAS RECEIVED A 2501 COMM ERROR FROM THE PATIENT PROGRAMMER. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413244 EON MINI SCS IPG GZB ST. JUDE MEDICAL NEUROMODULATION SYSTEMS 3788 2769768

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other SCS LEAD: MODEL 3219,| IMPLANT DATE: