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

Model Number	71005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the patient's records with nalu found no previous complaints or reports of issues with the system and the patient had previously indicated getting good pain relief, significant improvement in activity levels, and satisfaction with the system.The patient was previously being followed by a nalu employee who is no longer with the firm.The patient did not share any details with the current nalu representative as to approximate date of symptom onset or any other previous troubleshooting that was done.At the time of explant the system appeared to be functing as expected and placed appropriately.Cause of the lack of pain relief and reported "pinching" sensation are unknown and the system was not retained after explant and thus unavailable for further testing by the firm.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.In (b)(6) 2024 the patient indicated in a survey that the pain level had been reduced from 8/10 down to 3/10 with use of the nalu system.On 04/12/2025 a nalu representative was notified by the physician that the patient was scheduled to have the nalu system explanted.The representative met with the patient on the day of the scheduled procedure and was told by the patient that the system was no longer providing relief and was causing "pinching" when activated.The patient was offered reprogramming and other troubleshooting however refused and adamantly requested removal.Fluoroscopic imaging was done on (b)(6) 2025 prior to explant and the physician stated that there was no obvious migration or other issues with the system.A full system explant was performed on (b)(6) 2025.During the procedure the physician visually evaluated the system and placement and again noted that there was no obvious issues with the system or 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: 21915928
• Report Number: 3015425075-2025-00152
• Device Sequence Number: 8729281
• Product Code: GZF
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)230831(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/27/2025

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 Expiration Date: 08/31/2026
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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