BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2770382 · Received October 1, 2012

    Report

    Report Number
    1627487-2012-01772
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 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 AN 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 A TRIAL IMPLANT, A CSF LEAK OCCURRED AFTER THE NEEDLE WAS INSERTED. THE LEAD WAS NOT IMPLANTED AND THE TRIAL WAS ABORTED. THE PATIENT REPORTED HAVING A HEADACHE POSTOPERATIVE. THE PATIENT REPORTED THE HEADACHE WAS IMPROVING AND IS PENDING FOLLOW UP WITH HER PHYSICIAN.

    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 79 YR Required Intervention