BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792042 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02507
    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
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PT¿S STIMULATION SUDDENLY TURNS OFF BY ITSELF. SHE STATED WHEN THIS HAPPENS SHE ATTEMPTS TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND PROGRAMMER BUT HER PROGRAMMER SHOWS THE MESSAGE ¿NO IPG TELEMETRY¿. SHE STATED SHE DOES NOT HAVE ANY ISSUES CHARGING HER IPG. SHE ALSO REPORTED SHE HAD LOST WEIGHT AND FEELS LIKE HER IPG IS TILTED. 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 3170793

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT DATE: