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

Model Number	71020
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any system or component failure or malfunction prior to the explant and the patient reported that they had stopped using the nalu device due to other extenuating pain issues unrelated to the area being treated by the nalu device.The reason for explanting the system is mri conditionality.Although the initial reason for the surgical intervention was not due to any issue with the nalu system, the patient may require additional invasive interventions due to the difficulty in removing the nalu leads.
Event or Problem Description
A nalu peripheral nerve stimulator system was implanted on (b)(6) 2023 targeting the medial branch nerve to treat neck pain.In august 2025 the medical clinic notified a nalu representative that the patient was scheduled for a brain mri and would need to have the nalu system removed so that the scan could take place.An explant procedure was initiated on (b)(6) 2025 and the implantable pulse generator (ipg) was successfully removed.The physician dissected down the leads to the location of the tined portion before aborting the process.Physician noted being uncomfortable proceding any further with removal of the leads and closed the procedure with the leads remaining in place.The patient is currently unable to move forward with the mri with the leads remaining implanted.Patient has reported that they will reach out to the other doctor to explore other diagnostic options.If the mri is still required, then the patient will be referred to a different surgeon to remove the remaining leads.

• 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: 22846491
• Report Number: 3015425075-2025-00256
• Device Sequence Number: 4488373
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)230602(17)260602
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/19/2025

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: 06/02/2026
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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