BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 3060369 · Received April 11, 2013

    Report

    Report Number
    1627487-2013-05515
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 HAS BEEN EXPERIENCING DISCOMFORT IN HER BACK, STOMACH, CHEST, AND KNEE. IT WAS ALSO REPORTED THE PT HAS BEEN EXPERIENCING DEEP VIBRATIONS IN HER PELVIS THAT CAUSE HER TO LOSE BALANCE AND FALL. THE PT'S SYMPTOMS GO AWAY WHEN STIMULATION IS DEACTIVATED. REPROGRAMMING WAS ATTEMPTED TO NO AVAIL. THE PT MAY DECREASE STIMULATION FOR BETTER COMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155488 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 3719654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS ANCHORS: MODEL 1192 (2)| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788