BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2831871 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-14014
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 19, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-14015. IT WAS REPORTED THE PATIENT IS EXPERIENCING UNCOMFORTABLE STIMULATION AT HER OCCIPITAL (OFF LABEL) LEAD SITES. THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT. FLUOROSCOPY WAS DONE AND REVEALED THE LEAD ON THE RIGHT SIDE HAD FLIPPED. THE PATIENT UNDERWENT REVISION SURGERY WHERE THE PHYSICIAN REPOSITIONED THE LEAD. IT WAS NOTED THE MOST PROXIMAL CONTACT FELL OFF THE LEAD DURING THE PROCEDURE. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3268 3161120

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: