MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71005
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2022 to treat lower bac pain.The implantable pulse generator (ipg) was placed in the lower back area with the leads in the vicinity of t8-t10.In (b)(6) 2023 the patient reported some skin irritation from the external adhesive clips and switched to a silicone style adhesive clip to reduce skin reaction.The skin irritation was alleviated and no further issues were reported after changing adhesive type until (b)(6) 2025.On (b)(6) 2025 the patient contacted a nalu representative and provided a picture of skin breakdown with what appeared to be an open wound.The patient was instructed to follow up with the physician.Physician noted that the wound was over top of the location where the ipg was implanted, however not at any incision sites and appeared superficial and not affecting the ipg.Due to the proximity of the wound to the location of the ipg, the physician elected to explant the nalu system.Swabs were taken at the time of explant and sent for lab cultures however the results of the culture are unknown at the time of reporting.
Additional Manufacturer Narrative
There were no signs of infection until more than 2 years after the nalu device was implanted, indicating that the implanted components are not likely to be the source or cause of the infection.The patient has been observed by nalu representatives to have a history of skin irritation and poor personal hygiene.The location of the wound corresponds with the location where the nalu adhesive clips would have been placed.It is likely that the patient behavior with regards to cleaning and hygiene at the clip location contributed to skin breakdown.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 21923319
• Report Number: 3015425075-2025-00156
• Device Sequence Number: 19889187
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)220525(17)250525
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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 Expiration Date: 05/25/2025
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown