MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	72011
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any infection being present at the time of explant.No reports of any trauma or excess activity from the patient.The patient is noted to have a very low bmi and chronic steroid use, however it is unclear if those conditions played a role in the implant eroding through the skin and becoming exposed.
Event or Problem Description
The patient was implanted with a nalu nerve stimulator system on (b)(6)2024 to treat upper back pain.On (b)(6) 2025 the patient noted that the lead implanted in the thorasic paraspinal tissue appeared to be eroding through the skin.The physician was notified and the patient was seen on (b)(6) 2025 for evaluation.Upon examination, the physician determined that the anchor holding the lead in place was migrating up and through the skin.No redness, swelling, or discharge was noted at any of the surgical sites or the location of the exposed implant.All lab cultures were reported as normal and the patient stated no fever or chills.On (b)(6) 2025 the physician removed the exposed lead, irrigated the site with antibiotics, and closed the site, leaving the implantable pulse generator (ipg) and the second implanted lead in place.The patient was administered oral antibiotics for home use as a precaution.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21684448
• Report Number: 3015425075-2025-00128
• Device Sequence Number: 18450175
• Product Code: GZF
• UDI-Device Identifier: 00812537037226
• UDI-Public: (01)00812537037226(11)240719(17)270719(10)9457569
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/24/2025

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 Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 9457569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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