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

Model Number	71020
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Excessive Heating (4030)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mri facility was provided with the patient's nalu implant data prior to initiating the scan.A remote impedance check was performed on the nalu system on (b)(6) 2025, within one week of the scan, and returned all good impedances.A follow-up remote impedance check was conducted after the mri scan and returned all good impedances.The patient reports that the nalu device is delivering appropriate stimulation after the scan event.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat right lower extremity pain.On (b)(6) 2025 the patient was seen for an mri scan.During the scan, the patient experienced some heating sensation and the extremity where the nalu device was implanted had some involuntary movement.The scan was stopped upon experiencing those sensations and the mri facility reported no harm to the patient.
Additional Manufacturer Narrative
The mri facility was provided with the patient's nalu implant data prior to initiating the scan.A remote impedance check was performed on the nalu system on 04/14/2025, within one week of the scan, and returned all good impedances.A follow-up remote impedance check was conducted after the mri scan and returned all good impedances.The patient reports that the nalu device is delivering appropriate stimulation after the scan event.Investigation concluded that the heating sensation felt is likely related to the patient's pre-existing passive implant and the nalu implant both being present in the same vicinity while in the mri environment.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat right lower extremity pain.On (b)(6) 2025 the patient was seen for an mri scan.During the scan, the patient experienced some heating sensation and the extremity where the nalu device was implanted had some involuntary movement.The scan was stopped upon experiencing those sensations and the mri facility reported no harm to the patient.

• 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: 22067394
• Report Number: 3015425075-2025-00159
• Device Sequence Number: 15793625
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)220425(17)250425
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2025

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: 04/25/2025
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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