BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C

    MDR report key: 2903192 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-15002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ST JUDE MED - 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 MED 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 MED HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS EXPERIENCING MUSCLE SPASMS IN HER RIGHT FOREARM. THE PT IS EXPERIENCING THE MUSCLE SPASMS EVEN WHEN STIMULATION IS TURNED OFF. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349 LAMITRODE 44C SCS LEAD LGW ST JUDE MED - NEUROMODULATION 3245 3789218

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention