BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4202041 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-21676
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 (AUSTRALIA) WAS DIAGNOSED WITH CAUDA SYNDROME AND HAS BEEN EXPERIENCING INEFFECTIVE STIMULATION FROM THE SCS SYSTEM. THE PHYSICIAN IS CONSIDERING ALTERNATIVE TREATMENTS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670296 UNK SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS IPG, MODEL: UNK