BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3891694 · Received June 9, 2014

    Report

    Report Number
    1627487-2014-25426
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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 EXPERIENCED A CEREBROSPINAL FLUID LEAK DURING HIS TRIAL PROCEDURE ON (B)(6) 2014. A BLOOD PATCH WAS PERFORMED TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED AFTER THE PROCEDURE THE PATIENT WAS EXPERIENCING NAUSEA AND A DECREASE IN BLOOD PRESSURE. IN TURN, THE PHYSICIAN EXPLANTED THE PATIENT'S TRIAL LEAD AND ABANDONED THE PROCEDURE. THE PATIENT'S SYMPTOMS RESOLVED POST-OP. FOLLOW-UP REVEALED THE PATIENT WAS SEEN BY THE PHYSICIAN AND THE ISSUES HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336589 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3086 4469092

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other