BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2792124 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-02476
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    July 23, 2012
    Report Date
    September 18, 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 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 NO LONGER FEELS EFFECTIVE STIMULATION IN HER LOW BACK AREA. REPROGRAMMING EFFORTS WERE ABLE TO PROVIDE SOME LOW BACK AND LOWER EXTREMITY COVERAGE. THE PT REPORTED HER STIMULATION CHANGED AFTER SHE HAD BEEN IN A CAR ACCIDENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 2825338

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE: