BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4181346 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-23521
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PT HAS NOT USED OR CHARGED HER IPG IN APPROXIMATELY 1 OR 2 YEARS. THE SJM REPRESENTATIVE MET WITH THE PT AND WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE IPG. IT WAS ALSO REPORTED THE PT EXPERIENCED DISCOMFORT AT THE IPG SITE. THE PT WILL CONSULT WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459031 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3497925

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: