BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3142094 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-04656
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. THE PT MET WITH THE PHYSICIAN AND REPROGRAMMING INITIALLY PROVIDED MORE EFFECTIVE STIMULATION. THE PT WAS SCHEDULED FOR STEROID INJECTIONS, AND IT WAS REPORTED THE PAIN WAS A NEW PAIN PATTERN. F/U IDENTIFIED THE PT WAS ONCE AGAIN REPORTING INCREASED BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233259 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 3706154

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: