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	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025.During a routine reprogramming appointment n (b)(6) 2025 the patient reported that pain symptoms seemed to be worsening since the implant and the system was not providing releif.The system was tested and returned normal impedance levels and the patient reported sensation of stimulation at very low power settings.Imaging was done and confirmed the tined leads had migrated forward.On (b)(6) 2026 a surgical intervention was performed to remove the migrated leads and place new leads at the intended nerve target.
Additional Manufacturer Narrative
The patient is reported to have normal tissue quality and be relatively sedentary, with no reports of any specific events that took place after the implant which may have contributed to lead migration.There was notable bruising present after the implant, causing the physician to delay any surgical intervention to see if allowing additional healing time would resolve the complaint symptoms.No conclusive determinations are able to be drawn as to the cause of the lead movement, however migration is a known inherent risk of implantable neuromodulation devices.

• 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: 24393247
• Report Number: 3015425075-2025-00365
• Device Sequence Number: 16078332
• Product Code: GZF
• UDI-Device Identifier: 00812537037691
• UDI-Public: (01)00812537037691(11)250718(17)280718(10)94595262X
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/04/2026

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 94595262X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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