BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843459 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02669
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    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 FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PATIENT NO LONGER WANTED HIS SCS SYSTEM AND THE PHYSICIAN CONSEQUENTLY REMOVED IT. IT WAS REPORTED THE SYSTEM WAS FUNCTIONAL AT THE TIME OF EXPLANT. FOLLOW-UP IDENTIFIED THE PATIENT HAD COMPLAINED OF RINGING IN HIS EARS. THE PHYSICIAN ALLEGEDLY EXPLAINED THE RINGING WAS UNRELATED TO THE SCS SYSTEM; HOWEVER, THE PATIENT INSISTED ON HAVING THE SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3165988

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)