MAUDE Adverse Event Report: NALU MEDICAL NALU NEUROSTIMULATION KIT; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number S100 SILICONE CLIPS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 02/06/2022

Event Type  Injury  

Event Description

When nalu clip was removed, the underlying skin is erythematous and tender to touch.There is soft tissue atrophy in the area as well as some thinning of the skin noted.It has caused atrophy of skin and soft tissue and skin irritation due to topical agent as well as a rash.I have tried all four of the adhesive clips for the nalu external device to power the internal ipg for the spinal cord stimulator and all of them have caused this type of irritation over the last two years almost exactly 2 years and we have not found a solution to this issue.The consulting wound surgeon is concerned that continuing to use the external device with the adhesive clip will begin to show skin breakdown with potential infection of the underlying nerve stimulator.Fda safety report id# (b)(4).

• Brand Name: NALU NEUROSTIMULATION KIT
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): NALU MEDICAL
• MDR Report Key: 13584355
• MDR Text Key: 286083762
• Report Number: MW5107625
• Device Sequence Number: 2
• Product Code: GZB
• 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: 02/17/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: S100 SILICONE CLIPS
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White