BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3649097 · Received December 30, 2013

    Report

    Report Number
    1627487-2013-19958
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    November 1, 2013
    Report Date
    December 3, 2013
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT IS W/O STIMULATION AND EXTERNAL DEVICES ARE UNABLE TO COMMUNICATE WITH THE SCS IPG. AN SJM REP CONFIRMED THE IPG IS INOPERABLE. THE PT WAS REFERRED TO A SURGEON FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679992 EON MINI GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3864033

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS LEAD: MODEL 1194 (2)| SCS LEAD: MODEL 3219| IMPLANT DATE: