BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2892856 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-14284
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED (DATE UNKNOWN). THERE WERE NO KNOWN ISSUES REPORTED REGARDING THE PATIENT'S SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3063032

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)