BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3954938 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-12483
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 20, 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 THAT THE PATIENT HAS NOT RECEIVED EFFECTIVE STIMULATION IN HIS LOWER LEG AND FOOT SINCE THE IMPLANT. REPROGRAMMING AS UNABLE TO PROVIDE EFFECTIVE STIMULATION. X-RAYS TAKEN SHOWED NO ANOMALIES AND THE PATIENT DENIES ANY FALLS OR TRAUMA. THE PATIENT HAS EFFECTIVE STIMULATION IN THE REST OF HIS ESTABLISHED PAIN PATTERN. THE PHYSICIAN PLANS A TRIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416047 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3219 4103504

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS IPG: MODEL 3788,| IMPLANT DATE: