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 Code	Inadequate Pain Relief (2388)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any events leading up to the lead migration that are likely to have contributed to the event.The tissue quality at the site of the implant is noted to be loose and unstable, possibly causing the leads to shift.The nalu system is not approved to treat migrain pain, thus this application of the system is off-label and the firm is unable to confirm expected effectivity of the system for this application.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat off-label migraine related to head and neck pain.After activating the system, the patient reported frequent communication issues between the ipg and external therapy discs.Patient also reported inadequate pain relief while the system was connected and running stimulation.Multiple surgical interventions were done, including repositioning the existing implant on (b)(6) 2025 (see mdr 3015425075-2025-00260) and a second relocation of the implant as well as replacement of the leads on (b)(6) 2025 (see mdr 3015425075-2025-00254).During the procedure in (b)(6) 2025 the implantable pulse generator (ipg) was relocated from the intraclavicular area to the posterior shoulder area to provide more stable tissue to support the implant.On (b)(6) 2025 the firm was notified that the patient's pain symptoms had again increased.The physician used imaging to confirm the new leads that were placed at the occipital nerve had migrated.The physician noted that there was no suspicion of any component malfunction so the plan would be to reposition the existing occipital lead.During the procedure on (b)(6) 2025 the physician replaced the migrated lead rather than repositioning the existing one.

• 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: 23626743
• Report Number: 3015425075-2025-00329
• Device Sequence Number: 9072417
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)241204(17)271204(10)9458385
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 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): 11/22/2025

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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9458385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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