BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL NEEDLE, 14 GAUGE, 4"

    MDR report key: 2190743 · Received July 26, 2011

    Report

    Report Number
    1627487-2011-06027
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    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

    DURING A TRIAL IMPLANT PROCEDURE, IT WAS REPORTED THAT CEREBROSPINAL FLUID WAS OBSERVED ONCE THE PHYSICIAN INSERTED THE EPIDURAL NEEDLE. THE CASE WAS ABORTED, AND THE NEEDLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL NEEDLE, 14 GAUGE, 4" SPINAL CORD STIMULATION LEAD ACCESSORY LGW ST. JUDE MEDICAL - NEUROMODULATION 1114 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention