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

Model Number	72006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower extremity pain.The patient had reported pain levels decreased from 9/10 down to 2/10 while using the trial system and in a survey completed on (b)(6) 2024 pain levels were reported to be 3/10 with the patient reporting satisfaction with the system and being highly likely to recommend it to others.In (b)(6) 2024 the firm was notified that the patient was only getting minimal pain relief and wanted to explant the nalu system so that an mri could be completed.At this time the patient became unresponsive to communication from the firm.On (b)(6) 2025 the firm was able to make contact with the patient and learned that the nalu system had been explanted some time in (b)(6) 2024, exact date was unknown.The patient stated that it felt as if the stimulation from the nalu system was not getting to the right place and thus the minimal pain relief and desire for explant.
Additional Manufacturer Narrative
Patient reports are somewhat conflicting as pain relief appears to have been good in (b)(6) 2024 and then inadequate in (b)(6) 2024.There are also reports of the patient having other unspecified issues with the lower extremity and the need for an mri.Based on the sudden change of pain coverage and the patient's statement regarding stimulation being in the wrong location, it is suspected that the leads migrated away from the intended nerve target, causing change in therapy and reduced pain relief.The patient did not provide any additional information around any events that may have contributed to the leads moving.No xrays or other imaging was made available to the firm to verify lead position prior to explant and nalu was not aware of the scheduled procedure until after it had already taken place.Migration is a known inherent risk of implantable neuromodulation systems and is suspected to be the reason for the change in therapy and subsequent request for explant.

• 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: 21673421
• Report Number: 3015425075-2025-00116
• Device Sequence Number: 8179955
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)240326(17)270326(10)9456936
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2024
• 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): 03/22/2025

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9456936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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