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

Model Number	71019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Presence of infection was confirmed via lab cultures, however the type of bacteria present was not shared with the firm.The infection developed at an incision site, in the area where the external devices were being worn.The infection is reported specifically at the incision site and not within the ipg pocket, thus it is unlikely that the infection was from the implant itself.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat shoulder pain.The implantable pulse generator (ipg) was placed in the posterior shoulder area with the implanted leads targeting the left suprascapular nerve.After implanting the system, the patient developed infection at the ipg incision site and a full system explant was performed on (b)(6) 2025.

• 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: 22881255
• Report Number: 3015425075-2025-00265
• Device Sequence Number: 9971679
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)250106(17)280106
• 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): 08/22/2025

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: 08/18/2025
• Initial Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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