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

Model Number	72007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A nalu representative was present for the revision procedure and observed no obvious reason for the anchored tined lead to have migrated.There are no reports of any events leading up to the change in therapy and onset of discomfort.In addition to the migration, it appears that the original lead placement was inadequate to address the origination of the patient's pain.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat back pain.On (b)(6) 2026 the patient presented at the medical clinic with complaints of pain in the right leg.Assessment by the physician determined that the lead had migrated and was placing pressure on the exiting nerve root, causing the pain symptoms.Additionally, the reported pain pattern that was intended to be treated with the nalu system was assessed and determined that the placement of the system was not appropriate for the pattern.On (b)(6) 2026 a surgical revision was performed to correct the lead placement.The patient had initially been implanted with the implantable pulse generator (ipg) placed in the lower back with the leads targeting the l3 area of the medial branch nerve.Tined leads were used and the leads were also sutured in place.The revising physician was able to fully remove the migrated lead as well as the second lead and ipg.The system was replaced with bilateral superior cluneal placement with the ipg remaining in the flank area but slightly more lateral on the left side.

• 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: 24722392
• Report Number: 3015425075-2026-00040
• Device Sequence Number: 10331786
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)240807(17)270807(10)9457631
• 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: 2025
• 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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9457631
• 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: 08/07/2024
• 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