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 Code	Inadequate Pain Relief (2388)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient reports no specific events or activities taking place after the implant that may have contributed to migration of the system components.The patient is reported to have loose, fatty tissue at the implant location and the soft tissue quality is noted to potentially provide inadequate support to stabilize the implanted components.It is possible that the choice of location for the implant in unstable tissue allowed the ipg and lead to move away from the original implant location.It is unknown if the patient had any other potential implant locations that would have provided more suitable tissue for the device with still addressing the location of pain.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(5) 2025 to treat knee pain.After activating the system and using it for a short time, the implantable pulse generator (ipg) was found to be beyond the recommended depth for optimal connectivity and one of the implanted leads had migrated away from the intended nerve target.On (b)(6) 2026 a surgical intervention was performed to reposition the affected components.During the procedure the lateral lead and the ipg were damaged and required replacement.

• 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: 24754269
• Report Number: 3015425075-2025-00369
• Device Sequence Number: 12956846
• Product Code: GZF
• UDI-Device Identifier: 00812537037691
• UDI-Public: (01)00812537037691(11)250718(17)280718(10)94595262X
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/04/2026

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 94595262X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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