MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	71020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The state of the nalu system is unable to be fully assessed at the time of initial investigation due to the system remaining implanted and no imaging available for review.The patient report of discomfort at the ipg site may potentially be related to the position of the ipg at a bony location, however this is also unable to be fully assessed without further imaging or physical examination to assure the ipg has not migrated.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system targeting the suprascapular nerve on (b)(6) 2026 after participating in a successful trial phase with nalu.The patient also participated in a wear study with nalu prior to implanting the permanent system.During the wear study the patient selected a preferred location for the external components, which directs the implant location for the implantable pulse generator (ipg).During the implant procedure on (b)(6) 2026 the patient was positioned on the operating table in a manner that prevented the physician from tunneling to the location chosen for the ipg placement and thus the device was placed in a different location.On (b)(6) 2026, 2 weeks after the implant, the patient contacted a nalu representative stating that the ipg placement over the collarbone area was causing pain.The patient was instructed to reach out to the implanting physician for follow-up.On (b)(6) 2026, the patient was seen in the medical office.During that visit the patient reported to the nalu representative that there was a "crunching" sound and pain during arm movement.Additionally, the patient reported lack of pain relief from the nalu system.The physician recommended x-ray imaging to assess the position and condition of the implanted components.As of (b)(6) 2026 there has been no further information received regarding patient status and plan of care.

• 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 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50076673
• Report Number: 3015425075-2026-00070
• Device Sequence Number: 10744659
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)260205(17)290205
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 02/05/2026
• 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