BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2821139 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-02557
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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 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

    IT WAS REPORTED, THE STIMULATION TURNED OFF WHEN THE PT ATTEMPTED TO CHECK THE IPG BATTERY STATUS ON HER PROGRAMMER. DIAGNOSTICS TESTING REVEALED NO ANOMALIES WITH THE SCS SYSTEM. THE PT WAS REPROGRAMMED AND SUBSEQUENTLY SHE REPORTED HER RECHARGE BURDEN INCREASED. THE PHYSICIAN DECIDED TO EXPLANT THE IPG AND REPLACE IT WITH A DIFFERENT MODEL. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3350882

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: