BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123497 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04609
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 WAS UNABLE TO COMMUNICATE WITH THE IPG USING THE CHARGING SYSTEM. THE PT WAS ABLE TO COMMUNICATE WITH THE PROGRAMMER, AND HAD RECEIVED A LOW BATTERY FLAG. THE PT WAS NOT TURNING THE SYSTEM ON DUE TO THE FLAG. THE SJM REP MET WITH THE PT AND ATTEMPTED USING OTHER DEVICES AND WAS UNABLE TO RECHARGE THE IPG. THE PT STILL HAD STAPLES SO AN ATTEMPT WAS MADE ONCE THE STAPLES WERE REMOVED. IT WAS REPORTED THE PHYSICIAN ORDERED AN X-RAY WHICH SHOWED THE IPG WAS IN THE CORRECT ORIENTATION. WHEN THE IPG WAS PALPATED, IT WAS REPORTED THE DEVICE MAY BE TILTED WITHIN THE POCKET, BUT IT WAS NOT BELIEVED TO BE IMPLANTED TOO DEEP TO COMMUNICATE. IT WAS REPORTED THE PT WAS SCHEDULED FOR SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219558 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3926092

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE: