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

Model Number	72007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.The patient had participated in a successful trial phase with nalu prior to the implant.The patient was also an active participant in choosing the location for the implant per a wear study performed with nalu.The implantable pulse generator (ipg) was placed in the lower back area at the patient's chosen location, however the patient later reported discomfort at the site and requested explant.A full system explant was performed on (b)(6) 2025 per the patient's request.
Additional Manufacturer Narrative
The patient is reported to have a very high bmi and uses a back brace over the location of the nalu implant.Despite participating in a wear study and choosing the location for the implant, the patient later reported that the use of the brace over the implant caused the leads to be uncomfortable.The patient reports receiving good therapy from the system, but that the discomfort outweighed the relief.It is possible that the amount of lead coil was different between the trial and permanent implant, thus causing a false sense of comfort during the trial phase.Additionally, the wear study is primarily for identifying the location of the ipg and thus the external wearables.During the wear study the leads are not addressed.The location of discomfort for this patient is specifically noted to be at the lead coils.Patient use of a back brace at the site was an unanticipated comfort factor in placing the implant.

• 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: 22768333
• Report Number: 3015425075-2025-00247
• Device Sequence Number: 9585507
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)240830(17)270830(10)9457784
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 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): 08/10/2025

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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9457784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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