BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821036 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-25355
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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 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 DURING THE PT'S PERMANENT PROCEDURE ON (B)(6) 2014, THE PT EXPERIENCED CEREBROSPINAL FLUID LEAKS DUE TO THE PHYSICIAN HAVING DIFFICULTY ATTEMPTING TO PLACE THE LEAD AT THREE DIFFERENT LEVELS ON THE SPINAL CORD. AS A RESULT, THE PHYSICIAN DECIDED TO ABANDON THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN PERFORMED A BLOOD PATCH TO SEAL THE LEAKS. THE PT HAS REMAINED ASYMPTOMATIC SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276821 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3932310

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other