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

Model Number	71007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient stated that the therapy from the nalu system was not sufficiently effective despite several reprogramming's since being implanted.Review of records found that the patient had not been seen by the implanting physician or any nalu personnel for approximately one year prior to explanting the system.On (b)(6) 2023, the patient reported a reduction in pain from 7/10 down to 3/10, however on (b)(6) 2024, the patient had reported pain levels of 5/10.It is unclear why the patient had a change in therapy effectiveness.There are no known images to confirm placement of the leads prior to explant and there has been no report from the patient of any extenuating health issues or external traumas that may have exacerbated the pain symptoms.The explanted device was not retained for return to nalu and thus is not available for further inspection and examination by the firm to confirm functionality.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat knee pain.On (b)(6) 2025, the firm was contacted by an mri facility to request conditionality of the nalu system.Upon confirming that the patient was not conditional for an mri at the planned location, the facility reported that the patient was planning to explant the nalu system.A representative of nalu reached out to the implanting physician, dr.(b)(6), who confirmed no awareness of any issues with the system and no awareness of any plans for explant.The patient declined communication from nalu personnel until after the system was removed.On (b)(6) 2025, the patient notified the nalu representative that a full explant was performed on (b)(6) 2025 by dr.(b)(6).

• 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: 22147151
• Report Number: 3015425075-2025-00163
• Device Sequence Number: 20931153
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: (01)00812537030999(11)210720(17)240720
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/30/2025

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: 07/20/2024
• Device Model Number: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2021
• 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