BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052633 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-06129
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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'S SCS SYSTEM WAS EXPLANTED. THE PT REPORTED, THE SYSTEM WOULD TURN THE STIMULATION OFF AND ON WITHOUT PROMPTING AND DECIDED TO HAVE THE SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133722 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3527183

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention SCS LEAD: MODEL 3166 (X2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3346 (X2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3149 (X2)