BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3040145 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-05475
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2012 FOR AN UNK REASON. THE PT WAS TRANSFERRED TO A REHABILITATION FACILITY AFTER STAYING IN THE HOSPITAL FOR AN EXTENDED PERIOD OF TIME. AS A RESULT, THE PT WAS UNABLE TO RECHARGE HER IPG AS NEEDED. THE CHARGER AND PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG, DUE TO IT NOT BEING RECHARGED. THE PT PLANS TO UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136303 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3101638

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R SCS LEAD: MODEL 3228| IMPLANTED: