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

Model Number	71019
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no indications or allegations that any portion of the nalu system having failed or malfunctioned, as evidenced by all components remaining implanted and in use after both revision procedures.Per the implanting physician, the patient condition (low body mass) and superficial placement of the implanted anchors was the likely cause of the initial discomfort and was alleviated by placing the implanted components in a deeper position.The patient was then able to utilize the system for approximately 2 years with no record of complaint before again reporting discomfort at the lead site.There is no report of any event taking place within that time that may have contributed to the suspected lead migration.The patient is reported to have a very low bmi, possibly indicating insufficient tissue mass to support sustained implant stability in the active abdominal location.Migration of implanted components is a known inherent risk of neuromodulation systems and it is unknown how much the patient's body habitus and activities influenced the lead stability.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 to treat abdominal pain.After implant, the patient complained of localized pain or discomfort which the physician believed was related to the placement of the implanted anchors in conjunction with the patient's low body mass.On (b)(6) 2023 a procedure was performed to move the existing implanted leads and anchors to a less superficial position to alleviate the patient discomfort.No components were explanted or replaced during the procedure.See mdr 3015425075-2023-00302.The patient utilized the system for approximately 2 years before again reporting mild to moderate pain near the lead site.The physician assessed the patient and system and determined that the leads may have migrated distally, causing the discomfort.On (b)(6) 2025 a procedure was performed to loosen the anchors and reposition the existing leads, then re-anchor.No components were removed or replaced during the procedure.

• 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: 24737548
• Report Number: 3015425075-2026-00364
• Device Sequence Number: 9214323
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)220425(17)250425
• 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: 2022
• 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): 01/26/2026

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 Expiration Date: 04/25/2025
• 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: 12/31/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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