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

Model Number	71019
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The location of the implant is a highly used shoulder joint and the patient appears to be relatively active, leading to movement of the ipg and frequent disconnections.After repositioning the ipg, the physician noted suspicion of adipose tissue necrosis, possibly further affecting the stability of the ipg and allowing it to migrate.Depth testing and intra-operative stimulation testing was performed at each procedure to assure the device components were placed appropriately at the time of implant and at the time of each revision.
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.On (b)(6) 2025 the patient was seen for surgical procedure to move the implantable pulse generator (ipg) to lower on the shoulder and more medial to better support consistent connectivity between the ipg and the external therapy discs.During the procedure a migrated lead was also repositioned to be at the intended location to provide therapy at the site of pain.Approximately 1 month after the revision, the patient reported continuing challenges in maintaining connection between the ipg and therapy discs.On (b)(6) 2025 the patient was seen in the clinic and xray imaging found that the ipg had migrated beyond the recommended depth.On (b)(6) 2025 a second surgical revision was performed to remove the migrated ipg and place a new one in a more superficial position.During the procedure the leads were also replaced out of caution.

• 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: 24173455
• Report Number: 3015425075-2025-00351
• Device Sequence Number: 10149797
• 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
• 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): 01/24/2026

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: 12/30/2025
• Initial Report FDA Received Date: 01/24/2026
• 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