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

Model Number	71019
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripher nerve stimulator system on (b)(6) 2024 to treat shoulder pain.The implantable pulse generator (ipg) was placed in the badge area on the back of the arm with the leads targeting the axillary and suprascapular nerves.After the implant, the ipg migrated toward the patient's armpit area, making it challenging for the patient to access and place the external adhesive clips.The patient reported good therapy and was able to achieve connection between the ipg and therapy discs, however the location of the ipg after migration made it challenging for the patient to use the system.While assessing the system it was also determined that the axillary nerve had migrated slightly, although still providing stimulation.Additionally, the patient reported not having any pain symptoms in the upper arm and thus the axillary lead placement was not needed.On (b)(6) 2026 a surgical revision was performed to move the ipg to a high trapezius location for easier accessibility for the patient.During the procedure, both original leads were removed, and 2 new leads were implanted targeting the right suprascapular nerve only to address the patient's primary pain location in the shoulder.
Additional Manufacturer Narrative
There are no reports of any events or excessive activity leading to the migration of the implanted components.The tissue quality at the original ipg implant site is reported to be soft, possibly inadequate to provide suitable stability for the implanted device.There are no indications of any system or component failure beyond migration, which affected the system's usability.When in use, the patient reported receiving good therapy from the system.It may be pertinent that the patient has a history of total shoulder replacement prior to implanting the nalu system and it is unknown how that prior procedure may have affected the axillary nerve.

• 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: 24570093
• Report Number: 3015425075-2026-00033
• Device Sequence Number: 15843172
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)240207(17)270207
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/11/2026

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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