BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110771 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-15622
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    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 INFO 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

    IT WAS REPORTED THE PT BEGAN EXPERIENCING SEVERE HEADACHES THE DAY AFTER HIS TRIAL SYSTEM WAS IMPLANTED. THE PHYSICIAN INDICATED THERE WAS A PROBABLE CSR LEAK DURING THE TRIAL PROCEDURE. NO BLOOD BATCH WAS PERFORMED. NO BLOOD BATCH WAS PERFORMED AND NO MEDICATION WAS PRESCRIBED. THE PHYSICIAN INSTRUCTED THE PT TO LAY FLAT ON HIS BACK AND CONSUME LARGE AMOUNTS OF CAFFEINE. THE HEADACHES LATER RESOLVE AND THE PT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204800 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3961845

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention