BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2921428 · Received January 9, 2013

    Report

    Report Number
    2921428
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    PER THE SURGEON - FAILED OCCIPITAL NERVE STIMULATOR; POSSIBLE DEFECTIVE GENERATOR AND/OR LEAD. THE SURGEON REMOVED AND REPLACED THE OCCIPITAL NERVE STIMULATOR AND LEAD.======================MANUFACTURER RESPONSE FOR SPINAL CORD STIMULATOR, SPINAL CORD STIMULATOR GENERATOR (PER SITE REPORTER).======================REP TOOK THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13234 EON MINI STIMULATOR, SPINAL-CORD LGW ST. JUDE MEDICAL, INC. 3788 3610118
    13235 OCTRODE STIMULATOR, SPINAL-CORD LGW ST. JUDE MEDICAL, INC. 3186 340600

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR