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

Model Number	71003
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 after a successful trial phase with nalu.Patient had reported significant pain relief with the nalu system.On (b)(6) 2024, the implanting physician notified a nalu representative that the patient was being scheduled for a surgical revision due to reported issues with communication between the implantable pulse generator (ipg) and the external therapy discs.Prior to the physician notification, the firm had been unaware of any problems or concerns with the system.On (b)(6) 2024, the patient was brought in to the surgical center and a nalu representative attempted to perform an assessment of the system and possible troubleshooting.The medical facility declined to allow any contact between the nalu representative and the patient.The nalu representative was informed that the patient had discussed the case with the physician and decided to explant the nalu system.A full system explant was performed on (b)(6) 2024.Nalu representatives were not allowed to be present for the procedure and the device was discarded by the facility upon explant.
Additional Manufacturer Narrative
Review of records found no prior history of any incidents or complaints from this patient.The firm was not allowed any communication with the patient on the day of the procedure and thus no assessment was able to be completed while the device was implanted.Additionally, the device was not returned to the firm for evaluation.The information available is insufficient to determine if the communication issues were device related or due to patient behavior and training on use of the device.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21185489
• Report Number: 3015425075-2025-00027
• Device Sequence Number: 4287158
• Product Code: GZF
• UDI-Device Identifier: 00812537036113
• UDI-Public: (01)00812537036113(11)231122(17)261122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2024
• 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): 01/16/2025

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: 71003
• Device Catalogue Number: 71003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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