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

Model Number	71019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any underlying health conditions that may have contributed to poor healing and no reports of any suspicion of infection being present.After the surgical intervention that took place in june 2025, the patient was not in contact with nalu staff for several months.The nalu personnel working with this patient were not aware of any healing issues until several months after the surgery when the patient was seen in the clinic for a follow-up appointment and the physician noted the incision was not fully healed.It was noted that the lead coil may have been implanted such that it was not laying flat and may have placed some pressure under the incision site.Poor healing is also a known inherent risk of surgical procedures.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain.The implantable pulse generator (ipg) was placed in the lower back area with the leads targeting the cluneal nerves.On (b)(6) 2025 a surgical revision took place to reposition migrated leads (see mdr 3015425075-2025-00218).After the revision, the surgical incision site failed to heal as expected.On(b)(6) 2026 the system was fully explanted and a new system was placed in a slightly different position to encourage the previous site to heal.

• 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: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 24474836
• Report Number: 3015425075-2026-00015
• Device Sequence Number: 10230568
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)241203(17)271203
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/27/2026

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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