BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3810788 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-25320
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ST. JUDE MEDICAL: NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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

    THE PT REPORTED EXPERIENCING UNBEARABLE/EXCRUCIATING PAIN AT THE IPG SITE AND NOTICED A "BIG BUMP" AT THE SITE. ADDITIONALLY, THE PT REPORTED LOSING 15 TO 20 POUNDS SINCE IMPLANT. IN TURN, THE PT WILL UNDERGO SURGICAL INTERVENTION TO EXPLANT THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253946 EON MINI SCS IPG GZB ST. JUDE MEDICAL: NEUROMODULATION 3788 3244738

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS LEAD: MODEL: 3228| IMPLANT DATE: