BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960889 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-02514
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A 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 PT'S SCS IPG HAS MIGRATED. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427078 EON MINI SCS IPG GZB ADVANCED NEUROMODULATION SYSTEMS 3788 2884539

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS LEAD: MODEL 3219| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (X3)