BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961199 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-20052
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT'S SCS IPG IS INOPERABLE DUE TO NOT CHARGING IT FOR ABOUT 3 MONTHS. ALSO, THE PROGRAMMER DISPLAYS ERROR "COMM ERROR 2501". THE PATIENT IS TO CONSULT WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423322 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3434522

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other SCS ANCHOR, MODEL: 1192 (2)| SCS LEAD, MODEL: 3186 (2)| IMPLANT DATE:| SCS LEAD, MODEL: 3286| IMPLANT DATE:| IMPLANT DATE: