MAUDE Adverse Event Report: NEURAXIS, INC. IB-STIM; NON-IMPLANTED NERVE STIMULATOR FOR PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME

Lot Number 969701

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Pain (1994); Dizziness (2194)

Event Date 06/14/2023

Event Type  Injury  

Event Description

Patient with symptoms of worsening headache, back pain, dizziness with second device (neuraxis ib-stim) placement.Symptoms resolved after device removal.Reference report: mw5119047.

• Brand Name: IB-STIM
• Type of Device: NON-IMPLANTED NERVE STIMULATOR FOR PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
• Manufacturer (Section D): NEURAXIS, INC.
• MDR Report Key: 17246912
• MDR Text Key: 318363746
• Report Number: MW5119046
• Device Sequence Number: 1
• Product Code: QHH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 969701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White