BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4202716 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-23698
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT EXPERIENCED DIFFICULTY CHARGING HER IPG WITH THE NEW CHARGER. AS A RESULT, THE PT HAS NOT CHARGED HER IPG IN APPROX 6 MONTHS. THE PT WILL UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674238 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3479713

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3228