BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2861057 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-13147
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-13148. IT WAS REPORTED, THE PT FELT WHAT HE DESCRIBED AS S "SHARP" ELECTRICAL SHOCK AT HIS IPG SITE. IT WAS REPORTED, THE DISCOMFORT SUBSIDED APPROX AN HOUR AFTER DISCONTINUING THE STIMULATION. THE SYSTEM WAS TURNED BACK ON THE FOLLOWING DAY AND THE PT STATED, HE RECEIVED ANOTHER SHOCK. THE PT ALSO REPORTED WARMTH AT HIS IPG AND LEAD INCISION SITES. A SJM REP ADVISED THE PT TO KEEP THE SYSTEM OFF. THE PT TO F/U WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3792931

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: