BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792095 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-03494
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    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 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 SYSTEM WAS REPLACED DUE TO THE PATIENT NOT RECEIVING EFFECTIVE STIMULATION. THE ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 85244

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS EXTENSION: MODEL 3386 (2)| SCS LEAD: MODEL 3268| IMPLANT DATE:| SCS LEAD: MODEL 3262| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3208