BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792010 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02509
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 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

    IT WAS REPORTED THE PT LOST STIMULATION AND HER IPG CANNOT COMMUNICATE WITH HER CHARGER OR PROGRAMMER. THE PT REPORTED SHE STOPPED USING HER SCS SYSTEM ABOUT 6 MONTHS AGO SINCE HER LEFT LEG PAIN RESOLVED. SHE STATED SHE HAD NOT CHARGED HER IPG DURING THIS TIME. ACCORDING TO THE MFR¿S DEVICE REGISTRATION SYSTEM, THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2012. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2844879

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: