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	Discomfort (2330)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no specific events reported leading to the lead migration.The patient is reported to be relatively active, using their hands for work and participating in physical therapy.The implanted leads are placed so that they are going across the elbow joint, from the ipg in the upper arm to the median nerve in the lower arm.The implant location is a high mobility area and the patient actively uses that extremity for daily activities.It is unclear how compliant the patient was with post-op recovery restrictions while allowing the system to scar into place.
Event or Problem Description
Patient was implanted with a nalu pns system on (b)(6) 2025 and the system was activated on (b)(6) 2025.The system was implanted with the ipg placed in the lateral upper arm and the leads targeting the median nerve to treat right lower arm pain.The physician used both fluoroscopic and ultrasonic imaging during the implant procedure.The leads were sutured to the fascia at the time of implant.After using the system for some time the patient reported a sensation of the implanted lead "poking" near the thumb area.Assessment of the system found that the distal lead had migrated a few centimeters.On (b)(6) 2026 a surgical revision was performed to correct the migrated lead.During the revision, the physician was able to retract the migrated leads and return them to their original position.The leads were then sutured down to the fascia again to secure placement.

• 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: 24570092
• Report Number: 3015425075-2026-00020
• Device Sequence Number: 9561335
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)240508(17)270508
• 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
• 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): 03/11/2026

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: 02/25/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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