BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3931710 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-00375
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 29, 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
    GM
    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 1 OF 2 REFERENCE MFR REPORT #1627487-2014-00376. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED DIFFICULTY COMMUNICATING WITH THE IPG VIA THE PROGRAMMER. EFFORTS TO RECTIFY THIS ISSUE WITH USE OF A DIFFERENT PROGRAMMER PROVED UNSUCCESSFUL. ADDITIONALLY, THE PATIENT REPORTED INEFFECTIVE THERAPY RELIEF FROM THE LEADS AS STIMULATION WAS SAID TO BE POSITIONAL IN NATURE. DUE TO THESE ISSUES, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. THE DATE OF EXPLANT HAS NOT PROVIDED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367084 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 4328459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS EXTENSION, MODEL 3386| IMPLANT DATE: