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

Model Number	71019
Medical Device Problem Codes	Migration (4003); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The wear study performed prior to implanting the nalu system was to establish a comfortable and accessible location for the device to be placed and thus did not identify potential disruptions in therapy related to movement of the shoulder.At the initial implant the leads were not sutured into place, allowing the tined feature on the leads to be the sole stabilizer for the lead.The location of the implant is a highly used shoulder joint and the patient appears to be relatively active.It is likely that lead migration was affected by a combination of the highly used joint, active lifestyle, and lack of sutures or anchoring.
Event or Problem Description
On (b)(6) 2025 a nalu peripheral nerve stimulator system was implanted to replace a pre-existing neurostimulation system from a different manufacturer.The nalu system was placed such that the implantable pulse generator (ipg) was in the upper lateral shoulder area with the leads targeting the occipital nerves.The patient participated in a wear study prior to implanting the nalu system and confirmed being happy with the placement of the external components, however the location of the system was causing connectivity issues between the ipg and the external therapy discs.The connectivity issues were causing disruptions in therapy each time the patient would lift the arm to do activities such as exercising or reaching above the head.The patient also reported that the stimulation was being felt lower than the targeted pain area.The physician performed flouroscopic imaging and noted that the right-side lead had migrated down away from the intended target.On (b)(6) 2025 the patient was seen for surgical procedure to reposition the migrated lead and the ipg.The right lead was pushed back up to the intended location and the ipg was moved lower on the shoulder and more medial.

• 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: 23334092
• Report Number: 3015425075-2025-00304
• Device Sequence Number: 21319236
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)240903(17)270903
• 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
• 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): 10/19/2025

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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