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

Model Number	71020
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
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 the firm was contacted by an mri facility to request information on system mri conditionality.The facility was advised that the system was conditional for the specified scan area.The firm provided an mri checklist, including information as to implanted components and requirement to perform impedance check within 7 days of the scan.No further feedback was received at that time.On (b)(6) 2026 the firm was again contacted by an mri facility to request information on mri conditionality.During that communication the mri facility reported that, per the patient, a partial system explant had been performed with all or part of the leads having been abandoned and remaining implanted.Upon reaching out to the medical provider, the firm learned that the explant had been performed on (b)(6) 2026.The provider reported that the system had failed the impedance check and thus prevented an mri from being performed.The patient reportedly had not been using the system for some time and chose to explant rather than revise to correct the impedance.The explant was performed without any nalu personnel present and no further information was provided.
Additional Manufacturer Narrative
It is unclear when the system first returned impedance errors due to lack of communication from the patient and provider.Review of nalu records found no history of any complaints or concerns from this patient prior to the report in (b)(6) 2026 of partial explant.No conclusions are able to be drawn as to timeline or external factors leading up to the reported impedance errors.Most likely cause of impedance errors is a fracture of the lead or the connector between the lead and ipg, however this is also unable to be confirmed due to lack of information and no return of the explanted device.

• 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: 25356548
• Report Number: 3015425075-2026-00054
• Device Sequence Number: 21496069
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)231025(17)261025
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2026
• 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): 06/01/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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