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

Model Number	71020
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nalu peripheral nerve stimulator system was implanted on (b)(6) 2025 to treat shoulder pain.The patient had participated in a successful trial phase with nalu as well as a wear study prior to implanting the permanent system.The patient chose a location on the front clavicle area to place the implantable pulse generator (ipg) with the leads planning to target bilateral suprascapular nerves.Prior to the implant procedure, the physician and nalu representative performed measurements and the physician determined that 40cm leads would be used.Upon begining the procedure, the physician discovered that the chosen 40cm leads were not sufficient to reach from the nerve target to the patient's chosen ipg location.The physician consulted with the patient's spouse and placed the ipg in the posterior shoulder area instead of the front of the shoulder.The patient reported dissatisfaction with the location of the ipg and requested to revise the system to place the ipg at the original requested location.On (b)(6) 2025 the ipg was removed from the posterior shoulder and placed in the anterior clavicle area.Lead extensions were introduced to accomodate the new ipg location.No components were explanted or replaced and all original components remain implanted and in use with the addition of lead extensions.

• 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: 22881256
• Report Number: 3015425075-2025-00258
• Device Sequence Number: 9971721
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240123(17)270123
• 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
• 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): 08/22/2025

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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