MAUDE Adverse Event Report: NEUROGENX 4000PRO

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Was treated by a podiatrist for cidp (a type of peripheral neuropathy) with a neurogenx 4000 pro.The stem part of the treatment has resulted in a bad case of chronic tendonitis on the instep of my left foot.I initially had a problem with this condition on both feet after the treatment.I complained to dr (b)(6), and he prescribed naprozen 500mg 2x/day.However, i have finished the course of treatment and still have considerable discomfort.I sure hope the injury is not going to be permanent.I am using ice and ibuprofen, but i am awaking in the middle of the night with an intense pain/spasm at my instep.

• Brand Name: NEUROGENX 4000PRO
• Type of Device: NEUROGENX 4000PRO
• MDR Report Key: 3926562
• MDR Text Key: 16176078
• Report Number: MW5037096
• Device Sequence Number: 1
• Product Code: GZI
• 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: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR