BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980239 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02277
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    October 8, 2012
    Report Date
    January 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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 ADVISORY. 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 PT'S SCS SYS WAS REMOVED ON (B)(6) 2012. THE REASON FOR THE EXPLANT IS CURRENTLY UNK. IT WAS REPORTED THE PT UNDERWENT ANOTHER SURGICAL PROCEDURE AND THE PHYSICIAN DECIDED TO EXPLANT THE SYS AT THAT TIME. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78141 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3473778

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS LEAD: MODEL 3224 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)