BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950240 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-26517
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2014-26515. DURING A TRIAL PROCEDURE THE PHYSICIAN NOTICED A CSF LEAK (WET TAP). THE PATIENT EXPERIENCED A HEADACHE DURING THE PROCEDURE. THE LEADS WERE PLACED BUT THE PATIENT ONLY RECEIVED STIMULATION IN THE BACK AD NOT IN HIS LEGS AFTER THE CSF LEAK. THE PATIENT WAS TAKEN BACK TO THE PROCEDURE ROOM AND A BLOOD PATCH WAS PERFORMED. THE HEADACHE RESOLVED AFTER THE BLOOD PATCH WAS PLACED. FOLLOW UP INFORMATION IDENTIFIED REPROGRAMMING WAS UNABLE TO PROVIDE STIMULATION TO ALL PAIN AREAS. STIMULATION IS NOT WHERE IT WAS INTRAOPERATIVELY. IT WAS DETERMINED THE LEADS HAD MIGRATED. THE PHYSICIAN REPOSITIONED THE LEADS BACK DOWN TO T9 AND STIMULATION WAS REGAINED IN THE BACK AND BILATERAL LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360452 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4478775

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other