BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960446 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-01469
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 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 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

    IT WAS REPORTED THE IPG CANNOT COMMUNICATE WITH EITHER THE PT PROGRAMMER OR CHARGER. REPORTEDLY, THE PT HAS NOT RECHARGED THE SYSTEM IN THE PAST 3-6 MONTHS. SURGICAL INTERVENTION MAY BE CONSIDERED AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420450 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3165989

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS LEAD: MODEL 3166| IMPLANT DATE:| SCS LEAD: MODEL 3163| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186