BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903136 · Received January 2, 2013

    Report

    Report Number
    1627487-2012-03965
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    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

    A 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS 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

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2012-03964. THE PT HAS 2 SCS SYSTEMS. IT WAS REPORTED THE PT WAS EXPERIENCING AN INCREASE IN RECHARGE BURDEN WITH ONE OF HER SCS IPGS. SUBSEQUENTLY, THE PT WAS SCHEDULED FOR AN SCS IPG REPLACEMENT. F/U IDENTIFIED THE PT'S SCS IPG WAS REPLACED. IT WAS UNDETERMINED WHICH SCS IPG WAS REPLACED SO BOTH ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 174962

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3382 (2)