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

Model Number	71019
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Impedance issues were discovered on one of the implanted leads in (b)(6) 2025, more than 9 months after the initial implant.The patient had not reported any clinical signs or symptoms at that time.In (b)(6) 2025 the patient began to experience reduction in therapy, likely relating to the impedance issues that had been noted 2 months prior.It is likely that the patient had been experiencing a progressive component failure of either a single lead itself or the connection between the lead and ipg, leading to open circuit impedance errors.There is no known event that is likely to have initiated the component failure, however it is likely that the patient fall in (b)(6) 2025 accelerated the failure despite reports that there was no direct strike to the implant site.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat knee pain.On (b)(6) 2025, during a regular follow-up visit, the system was noted to have high impedance readings on 2 contacts of one of the implanted leads.In (b)(6) 2025 the patient reported reduction in therapy from the system.In (b)(6) 2025 the patient sustained a fall but reports no direct strike at the implant location.During a pre-mri system check on (b)(6) 2025 the system was again confirmed to have impedance issues.The patient is scheduled for an mri toward the end of 2025 and requested a system revision so that the mri can take place.On (b)(6) 2025 a full system replacement was performed to place a new implantable pulse generator (ipg) and new leads.All explanted components were discarded during the procedure and thus not available for further testing by the firm.

• 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: 22881253
• Report Number: 3015425075-2025-00263
• Device Sequence Number: 18634785
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240111(17)270111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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: 08/13/2025
• Initial Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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