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	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat head pain.The implantable pulse generator (ipg) was placed in the posterior shoulder area with the leads placed at the c2-c3 lateral masses, consistent with a cervical medial branch target.In (b)(6) 2025 the patient contacted a nalu representative to report loss of stimulation.The patient completed a remote impedance test and found the right (b side) lead showed impedance errors on all 4 contacts.Assessment of the system confirmed that lead was not delivering stimulation and had migrated away from the intended nerve target.On (b)(6) 2026 the patient was brought in for surgical revision.During the revision the lead was connected to a known-good ipg and confirmed that the lead itself was malfunctioning.The malfunctioning lead was removed and replaced as well as replacing the original ipg out of caution.
Additional Manufacturer Narrative
The patient is reported to be moderately active with normal activities of daily living.Patient travels periodically but does not participate in sports or any physical activity that would be expected to contribute to lead migration.Patient waited 3-4 months to do any basic home chores to allow for scar tissue to form and further anchor the lead and appears to have been fully compliant with post-implant recovery instructions.It is likely that device migration caused damage to the lead, leading to the impedance errors and loss of stimulation.Although there is no identifiable cause for the lead to have migrated, it is notable that the system was implanted for an off-label use.

• 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: 24723037
• Report Number: 3015425075-2026-00044
• Device Sequence Number: 18695930
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)250502(17)280502(10)9459043
• 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: 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): 03/27/2026

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: 9459043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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