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

Model Number	72001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/02/2025
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 to treat back pain.The system was activated on (b)(6)2025 with no complaints.Approximately 2 weeks after activation the patient was seen in the clinic for reprogramming to optimize therapy due to reduced response to the stimulation.Over the course of the following month the patient reported ongoing reduced efficacy of the system despite multiple reprogramming sessions, eventually reporting no therapy being received at all.Xray imaging was performed on (b)(6)2025 and confirmed one lead had migrated away from the intended nerve target, leading to the loss of therapy.A revision procedure was performed on (b)(6)2025 to remove the migrated lead and place a new lead back at the nerve target.
Additional Manufacturer Narrative
The tissue quality at the lead implant location is reported to be good and the leads were sutured in place at the time of implant with no notable complications reported from the procedure itself.The patient is reported to be highly physically active and it is suspected that there was a premature return to normal daily activities rather than allowing for the leads to fully scar into place.

• 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: 23275718
• Report Number: 3015425075-2025-00298
• Device Sequence Number: 18322354
• Product Code: GZF
• UDI-Device Identifier: 00812537037202
• UDI-Public: (01)00812537037202(11)250423(17)280423(10)9459006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 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): 10/12/2025

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: 72001
• Device Catalogue Number: 772001
• Device Lot Number: 9459006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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