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

Model Number	71020
Medical Device Problem Codes	Device Unsafe to Use in Environment (2918); Intermittent Communication Failure (4038); Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of nalu records found no reports from the patient of any system or component complaints.There are no records of any reported issues from this patient regarding efficacy of therapy or usability of the external devices.The information provided by the patient is unclear when those issues began or if they had ever been reported for troubleshooting assistance.It appears that mri conditionality was the primary reason for system explant, however the patient continues to be unable to move forward with the scan due to the lead fragment still implanted.Patient will require a second procedure to remove the fragment or will need an alternative diagnostic test.Plan at the time of this reporting is unknown.
Event or Problem Description
On (b)(6) 2024 the patient was implanted with a nalu peripheral nerve stimulator system to treat left shoulder pain.After having the system implanted, the patient expressed frustration regarding mri restrictions but did not report any other issues or concerns with the nalu system or its components.On (b)(6) 2025 the patient reached out to a local nalu representative to discuss mri conditionality.During the conversation on (b)(6) 2025, the patient reported that the nalu system had been explanted on (b)(6) 2025.Nalu personnel had not received any notification of the explant prior to patient notification on (b)(6) 2025.On (b)(6) 2025 the patient reached out to nalu product support for additional mri conditionality information and reported that at the time of explant the physician was unable to fully removed the tined end of the implanted lead and cut the end off, leaving the distal end of the lead implanted.During the product support call, the patient also alleged that therapy had been ineffective and that there were challenges using the external wearables which also affected delivery of therapy from the system.

• 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: 22723532
• Report Number: 3015425075-2025-00237
• Device Sequence Number: 8884440
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240110(17)270110
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/05/2025

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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