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

Model Number	71001
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of patient records found no indication of any failure or malfunction of the implanted components although the patient did consistently report minimal pain relief.There are no known images there was no request to remove the nalu system until the patient required an mri scan and per the physician, the mri need is the primary reason for explant.The firm was not notified of the scheduled explant date and thus was not present for the procedure.The device was not returned to nalu for inspection after removal.Cause of the lack of efficacy is unable to be determined with the information available.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2019 to treat foot pain.The nalu system was implanted and in use for more than 5 years when the firm was notified that the patient was requesting an explant.Per the physician, the patient needs an mri and the system that was implanted is not mri conditional.On (b)(6)2025 a representative from nalu was able to make contact with the patient and discovered that the explant had taken place in (b)(6) 2024 and was done due to inadequate pain relief.Follow-up with the physician found that the date of explant was (b)(6)2024 and the physician's office noted that the primary reason for explant was the need for mri.The physician noted that, secondary to mri needs, the patient was not able to achieve greater than 50% pain relief from the system during the time it had been implanted.

• 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: 21673435
• Report Number: 3015425075-2025-00110
• Device Sequence Number: 8119724
• Product Code: GZF
• UDI-Device Identifier: 00812537030937
• UDI-Public: (01)00812537030937(11)190125(17)200125
• 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: 2019
• 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): 03/23/2025

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: 01/25/2020
• Device Model Number: 71001
• Device Catalogue Number: 71001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2019
• 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