BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926322 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-08050
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. SJM HAS LIMITED INFO 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 WAS EXPERIENCING PAIN AND SHOCKING AT THE IPG SITE. THE PT IS PENDING F/U WITH HER PHYSICIAN AND AN SJM REP TO FURTHER EVALUATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355965 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2785806

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCCS LEAD: MODEL 3146| IMPLANT DATE: