BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2780261 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-02430
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    THE PATIENT UNDERWENT A PROCEDURE TO RECEIVE TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HER SCS TRIAL SYSTEM. IT WAS REPORTED SOME CLEAR LIQUID ESCAPED AFTER PLACING THE SECOND LEAD; THE PHYSICIAN WAS UNSURE WHETHER THE FLUID WAS CEREBROSPINAL FLUID (CSF) OR LOCAL ANESTHETIC. THE PATIENT REPORTED GOOD COVERAGE DURING INTRAOPERATIVE TESTING, BUT SHORTLY AFTER REPORTED A LOSS OF SENSATION IN HER LEGS. THE PHYSICIAN DETERMINED HE HAD INADVERTENTLY INJECTED LOCAL ANESTHETIC INTO HER CSF. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT AND REPORTED THE SENSATION IN HER LEGS RETURNED WITHIN AN HOUR. THE FOLLOWING MORNING THE PATIENT REPORTED SHE WAS IN GREAT PAIN AND WANTED THE TRIAL SYSTEM REMOVED. IT WAS REPORTED THE LEADS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3750431

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R