BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950241 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-00358
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 28, 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
    CA
    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 2 OF 2. REFERENCE MFR. REPORT # 1627487-2014-00357. IT WAS REPORTED THE PATIENT'S (B)(6) THERAPY COVERAGE WAS INADEQUATE. STIMULATION WAS REPORTEDLY NOT BEING DELIVERED TO THE CORRECT AREAS. IN ADDITION, IT WAS REPORTED THE PATIENT EXPERIENCED DIFFICULTY MAINTAINING COMMUNICATION WITH THE IPG CIA THE CHARGING SYSTEM. A DIAGNOSTIC TEST FOUND IMPEDANCE ISSUES FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE PATIENT'S LEAD. DURING THE PROCEDURE, A STERILE BREACH INVOLVING THE IPG OCCURRED. DUE TO THIS ISSUE AND THE PREVIOUSLY REPORTED COMMUNICATION DIFFICULTIES, THE PHYSICIAN ELECTED TO EXPLANT THE PATIENT'S IPG. THE SURGICAL PROCEDURE WAS EXTENDED REPORTEDLY LASTED TWO HOURS. ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTIONARY MEASURE, AND A REPLACEMENT IPG WILL BE IMPLANTED A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360788 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3733687

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other