BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2980023 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01194
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    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 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 WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PT UNDERWENT REVISION SURGERY WHERE THE PHYSICIAN ADDED A SECOND LEAD PERIPHERALLY (OFF LABEL USE) IN HER CHEEK TO GET MOUTH AND TEETH COVERAGE. THE SCS LEAD WAS NOT REMOVED, JUST DISCONNECTED FROM THE IPG. THE PT IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78703 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 2886967

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS EXTENSION: MODEL 3383| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: