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

Model Number	72007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat knee pain.On 08/27/2025 the firm was notified by the patient's medical clinic that a revision was being scheduled due to lead migration.On (b)(6) 2025 the original system was removed and a new system was implanted with the leads at the correct placement to target the area of pain.
Additional Manufacturer Narrative
There is no allegation or indication of any issue with the implantable pulse generator (ipg), however the ipg was replaced during the procedure out of caution to avoid any potential handling damage while placing the new leads.The date therapy began to lose efficacy is unknown as the patient was communicating directly with the medical staff and not with any nalu representatives.There were no reports received of any specific events leading up to the loss of therapy.Migration of implanted components is a known inherent risk and the information available is insufficient to draw any conclusions as to other factors that may have caused or contributed to the lead movement.

• 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: 23048213
• Report Number: 3015425075-2025-00278
• Device Sequence Number: 18584305
• Product Code: GZF
• UDI-Device Identifier: 00812537032900
• UDI-Public: (01)00812537032900(11)230802(17)260802(10)9455166
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/14/2025

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: 08/02/2026
• Device Model Number: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9455166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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