BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2770387 · Received October 1, 2012

    Report

    Report Number
    1627487-2012-12190
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R,1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD ACTION. SJM HAS LIMITED INFO 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

    DEVICE 1 OF 2. REF MFR REPORT #1627487-2012-12191. THE PT REPORTED THE CHARGER AND PROGRAMMER WERE UNABLE TO COMMUNICATE WITH ONE OF HIS TWO IPGS. THE PT REPORTS THIS SAME CHARGER AND PROGRAMMER ARE ABLE TO COMMUNICATE WITH THE OTHER IPG. THE SJM TM VERIFIED THE PT'S ISSUES. THE PT REPORTS HAVING X-RAYS AND BOTH IPGS ARE IN THE PROPER POSITION. THE SJM TM WILL DISCUSS REPLACING THE IPG WITH THE PT AND PHYSICIAN. SINCE THE SERIAL NUMBER OF THE IPG IN QUESTION IS UNK, BOTH IPGS IMPLANTED IN THIS PT ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3410924

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3225 (2)