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

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During this patient's initial implant procedure in (b)(6) 2025 the ipg was replaced and repositioned, including creating a second tunnel for placement.It is possible that the repositioning and re-tunneling created some instability in the surrounding tissue.The migration of the ipg occurred within about a month of the initial implant, seeming to indicate that the movement occurred prior to the development of scar tissue.There are no reports of any specific events taking place after the implant that are likely to have contributed to device movement.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower extremity pain.After activating the system, the patient noted challenges with connectivity between the implantable pulse generator (ipg) and the external therapy discs.Assessment of the system found that the ipg had migrated past the recommended depth for optimal connectivity.On (b)(6) 2026 a surgical revision was performed to reposition the ipg to a more superficial position.During the procedure the ipg failed testing, likely due to surgical handling damage, and was replaced.Implanted leads were not replaced and remain in use with the new ipg.

• 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: 24474834
• Report Number: 3015425075-2026-00014
• Device Sequence Number: 13319531
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)250825(17)280825
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/27/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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