BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4173859 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-05697
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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'S IPG HAD FLIPPED IN THE POCKET. FORTUNATELY, THE PATIENT DID NOT EXPERIENCE ANY ISSUES AS A RESULT. IN TURN, THE PATIENT'S IPG WAS REPOSITIONED AND SUTURED SECURELY. THE PROCEDURE TOOK PLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643054 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 4462341

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SCS ANCHORS: MODEL 1192 (X2)| IMPLANT:| SCS LEADS: MODEL 3186 (X2)| IMPLANT: