MAUDE Adverse Event Report: LUMBAR STEROID INJECTION, INJECTOR

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Arachnoiditis, Spinal (2390)

Event Date 03/17/2016

Event Type  Injury  

Event Description

I had a lumbar epidural steroid injection for l4/l5.During the injection, i felt excruciating pain.My symptoms worsened rapidly after this injection.In (b)(6) 2016, an mri revealed arachnoiditis.I was diagnosed with arachnoiditis and pain treatment is not helping, so i have had a trial spinal cord stimulation and will have surgery this month for the permanent spinal cord stimulator.

• Brand Name: LUMBAR STEROID INJECTION, INJECTOR
• Type of Device: LUMBAR STEROID INJECTION, INJECTOR
• MDR Report Key: 7181878
• MDR Text Key: 97080354
• Report Number: MW5074535
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 47 YR
• Patient Weight: 90