BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961069 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-24020
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 24, 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
    TX, US
    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 1627487-2014-24019. PATIENT RECEIVED TWO LEAD WITH SAME LOT NUMBERS. IT WAS REPORTED THAT THE PATIENT IS NO LONGER RECEIVING STIMULATION. DIAGNOSTICS INDICATED HIGH AND LOW IMPEDANCE VALUES. REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS REVEALED THAT BOTH LEADS HAVE PULLED OUT OF THE EPIDURAL SPACE. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413315 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4444720

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2),