BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3820896 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-02321
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 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 DURING THE PATIENT'S SCS TRIAL PROCEDURE, A CSF LEAK OCCURRED. THE PHYSICIAN PERFORMED A BLOOD PATCH. THE PATIENT WAS ASYMPTOMATIC POSTOPERATIVE. FOLLOW UP ON (B)(6) 2014 IDENTIFIED THE PATIENT COMPLAINED OF A HEADACHE WHEN THE TRIAL ENDED ON (B)(6) 2014. IN ADDITION, THE HEADACHE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286628 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4448033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other