BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4252728 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-01713
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 STIMULATION IS INEFFECTIVE. DIAGNOSTIC TESTING REVEALED LOW IMPEDANCE VALUES. SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710215 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3234964

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other IMPLANT:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1194| IMPLANT: