BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3193644 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-13966
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    THE PATIENT REPORTED SHE WAS NO LONGER ABLE TO COMMUNICATE WITH HER IPG USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. THE PATIENT STATED THE LAST TIME SHE USED HER SCS SYSTEM WAS ON (B)(6) 2013 AND EVERYTHING WAS WORKING FINE. THE PATIENT IS CURRENTLY WITHOUT STIMULATION. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. THE PATIENT IS TO MEET WITH HER PHYSICIAN TO DISCUSS POSSIBLE IPG REPLACEMENT. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287530 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3711607

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other SCS LEAD: MODEL 3186 (2)| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)