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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports from nalu field personnel working with the patient and physician indicate that the ipg was likely implanted slightly too deep initially and that no migration took place.There is no indication of any system or component failure and all original components remain implanted and in use.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2024 to treat pelvic pain.The implantable pulse generator (ipg) was placed in the lower back area with the implanted leads targeting the pudendal nerve.During a post-op appointment on (b)(6)2025 the patient was noted to have some difficulty with communication between the ipg and the external therapy discs and also reporting some pain in one lower extremity when the system is active.Testing and troubleshooting in the field found that the ipg appears to be parallel to the skin surface but slightly beyond the recommended depth.On (b)(6)2025 a surgical revision took place to move the existing ipg to a more superficial pocket location slightly superior to the initial placement.No components were removed or replaced during the procedure and no new components were implanted.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21728555
• Report Number: 3015425075-2025-00101
• Device Sequence Number: 9394707
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)240110(17)270110
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/29/2025

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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