BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4212797 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-02747
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ST JUDE MED - 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

    UDI (DI): (B)(4). SJM HAS LIMITED INFORMATION 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-02746. IT WAS REPORTED THE PT'S SCS SYS'S OCCIPITAL PLACEMENT (OFF-LABEL) LEAD HAS MIGRATED. AS A RESULT, THE PT DOES NOT HAVE EFFECTIVE STIMULATION THERAPY ON THE LEFT SIDE. FOLLOW-UP IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO REPOSITION AND SECURE THE LEAD. THE PT REPORTED RECEIVING EFFECTIVE STIMULATION THERAPY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678078 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3189 3835939

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788