BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL NEEDLE

    MDR report key: 3961194 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-03477
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 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 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2014-03478. IT WAS REPORTED DURING THE PATIENT'S TRIAL PROCEDURE, A CSF LEAK OCCURRED WHILE THE PHYSICIAN WAS ADVANCING THE EPIDURAL NEEDLE. THE PHYSICIAN APPLIED A BLOOD PATCH AND HAD THE PATIENT DRINK FLUIDS. THE PATIENT WAS SENT HOME ASYMPTOMATIC. HOWEVER, THE PATIENT HAD THE TRIAL SCS LEAD EXPLANTED AT THE EMERGENCY ROOM LATER THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413254 EPIDURAL NEEDLE SCS NEEDLE GZB ST. JUDE MEDICAL - NEUROMODULATION 1114 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention