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	Inadequate Pain Relief (2388)
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) 2023 to treat lower back pain.In (b)(6) 2025 an mri facility reached out to nalu to determine the patient's conditionality.Patient was confirmed to be conditional but the facility was advised to have a local firm personnel perform an impedance check prior to the scan.No follow-up was requested and it is unclear if the scan took place.In july 2025 the medical clinic reached out to a nalu representative to report that the patient was being schedule for a revision procedure due to lead migration.The clinic did not share the history or diagnostic methods for determining that the leads had migrated, however the patient reported that the system had not been used for more than one year and was hoping to reactivate.On (b)(6) 2025 the revision provedure was performed with the intention of placing new leads at the intended nerve target.While removing the migrated leads, the implantable pulse generator (ipg) was damaged due to handling and also required replacement.
Additional Manufacturer Narrative
Based on patient reports, the system was in use for less than one year before they stopped using it.The patient reports are unclear around the circumstances but did not indicate any specific event leading up to the loss of therapy.An mri conditionality request was made but there was no follow-up from the clinic or patient to move forward with the procedure and thus the system was not assessed at that time either.The physician noted that the leads originally implanted did not have tines and that was thought to contribute to instability in the lower back area.The physician elected to replace the original leads with tined leads to assist with stability.

• 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: 22768331
• Report Number: 3015425075-2025-00251
• Device Sequence Number: 21228828
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: (01)00812537036441(11)230816(17)260816
• 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: 2023
• 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 Expiration Date: 08/16/2026
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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