BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE

    MDR report key: 3950508 · Received July 10, 2014

    Report

    Report Number
    1627487-2014-12457
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 19, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    IT WAS REPORTED THE PT EXPERIENCES WEAKNESS AND NUMBNESS IN HIS LEFT ARM, FROM HIS ELBOW TO FINGERS. THE PT REPORTED ISSUE STARTED THE DAT AFTER THE PERMANENT IMPLANT AND THE ISSUE HAS NOT RESOLVED. THE PT HAS BEEN SEEN BY A NERVE SPECIALIST AND TESTING WAS DONE. THE PT REPORTED THE WEAKNESS HAD RESOLVED BUT STILL HAS PAIN AND TINGLING FROM HIS ELBOW TO FINGERS. THE PT HAD A CT SCAN. THE PT DOES NOT HAVE THE RESULTS OF THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403854 LAMITRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4462267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other SCS IPG, MODEL 3788| IMPLANT DATE