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

Model Number	72001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any events leading up to the change in patient symptoms.The patient is reported to have a very low bmi and minimal tissue at the implant site.The implant procedure utilized sutures through the fascia to anchor the lead in place.Patient is thought to have been sufficiently compliant with post-operative recovery instructions, however it is unknown how compliant the patient was while at home.There were no reports of any symptoms of infection prior to beginning the revision procedure on (b)(6) 2026 and no lab cultures were taken to confirm presence or type of infection.The patient was reported have questionable hygiene, possibly contributing to development of suspected infection.The initial reason for surgical intervention is to correct lead migration.The decision to fully explant was based on a secondary assessment of the site upon beginning the procedure.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2026 to treat shoulder pain.The implantable pulse generator was placed in the posterior shoulder area with the leads targeting the suprascapular nerve.In mid (b)(6) 2026 the patient reported increased pain when the nalu system was active.Patient was instructed to turn off the system at that time.Imagine confirmed the implanted lead had migrated, likely causing the increased pain with active stimulation.On (b)(6) /2026 the patient was brought into the operating room to prepare for a revision procedure to reposition the lead.While draping the patient the physician noted that the implant incision site was red and had purulent drainage.Upon assessing the site the decision was made to fully explant the system, irrigate with antibiotics, and allow the site to heal.

• 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: 24722326
• Report Number: 3015425075-2026-00039
• Device Sequence Number: 10215717
• Product Code: GZF
• UDI-Device Identifier: 00812537037202
• UDI-Public: (01)00812537037202(11)251029(17)281029(10)9460116
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/26/2026

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: 72001
• Device Catalogue Number: 72001
• Device Lot Number: 9460116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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