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

Model Number	72006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient reports performing normal day to day activities with no specific events that may have caused or contributed to lead migration.The leads were sutured into place at the time of implant and tissue quality at the implant site is reported to be firm and appropriate to support the device.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat back pain.In approximately (b)(6) 2025 the patient noted a reduction in pain relief as well as reported muscle spasms.The patient requested reprogramming and was seen several times to reduce the intensity without improvement of symptoms.Imaging was done and revealed the leads had migrated away from the initial placement.On (b)(6) 2025 a surgical revision was performed to reposition the 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: 23565865
• Report Number: 3015425075-2025-00326
• Device Sequence Number: 18693503
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)240725(17)270725(10)9457571
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/16/2025

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9457571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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