BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850542 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-21336
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 REC'D A CERVICAL AND THORACIC SCS SYSTEM. THE PT REC'D TWO THORACIC LEADS WITH THE SAME LOT NUMBER. THE PT REPORTED EXPERIENCING SHAKING WHEN THE THORACIC SYSTEM IS ACTIVATED. THE PT HAS RSD TREMORS, HOWEVER, THE SHAKING IS AGGRAVATED WITH STIMULATION AND MAKES HER FEEL EXHAUSTED. REPROGRAMMING HAS BEEN UNSUCCESSFUL. F/U IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION TO ELECTIVELY EXPLANT AND REPLACE THE IPG AND SINCE HAS REC'D EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317264 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3578508

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788