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

Model Number	71007
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of explant the nalu system had not been activated by any nalu personnel and the patient adamantly refused to allow any troubleshooting by nalu personnel.A nalu representative present at the explant procedure reported no obvious signs of any system damage, malposition, or migration.Cause of the rc error message is unable to be conclusively determined due to patient being uncooperative, however it is likely that the issue stems from lack of training with the patient on how to use the system.The patient was provided only a high level training at the time of implant and would normally have been provided more in depth training at the post-op follow-up visit.Suspect patient misuse of the system and subsequent uncooperative behavior directly caused the error message noted by the patient and the system failure to function as designed.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 after a successful trial phase.During the trial, the patient reported reducion in pain levels from 7/10 down to 2/10.A permanent system was implanted on (b)(6) 2024 using ultrasound, placing the implantable pulse generator (ipg) in the calf area with the leads targeting the tibial nerve to treat left foot pain.At the implant procedure, several preliminary programs were uploaded to the nalu system and the patient was given instructions on use of the system.The programs given at the implant date typically require reassessment and updating at future post-op follow-up appointment and when the system is activated by a nalu representative.After the implant procedure the patient reported to the physician that he was unable to use the system due to the remote control (rc) application failing to communicate with the nalu system and continuously reporting "searching, please wait".Patient claimed that the system does not work and requested to remove it.Physician recommended to have a nalu representative assess the system and programs, however the patient adamantly refused to allow any troubleshooting by nalu personnel.A full system explant was performed on (b)(6) 2024 per the patient's request.

• 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: 21061036
• Report Number: 3015425075-2025-00001
• Device Sequence Number: 8153202
• Product Code: GZF
• UDI-Device Identifier: 00812537036144
• UDI-Public: (01)00812537036144(11)230921(17)260921
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/02/2025

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 Expiration Date: 09/21/2026
• Device Model Number: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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