MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Between (b)(6) 2024 and (b)(6) 2026 there are no records of any complaints or device replacements for this patient.The information available is unclear if the patient had continued to experience ongoing connectivity challenges during that time or if there were newly developed issues in 2026.Upon replacing the ipg, the original implanted device was not made available for further testing and investigation by the firm.Reports from the nalu representative present at the procedure indicate that the ipg returned good impedance readings and connectivity at the begining of the procedure but then was unable to connect after that initial testing.Good impedance readings were received when testing a new ipg with the original existing leads, indicating no issue with the leads and pointing to challenges being related to the original ipg.The ipg was removed from the pocket and tested again, with failing connectivity, indicating that position and depth were not likely a contributing factor.No further conclusions as to the cause of the device malfunction are able to be drawn with the information available.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023, targeting bilateral cluneal nerves.In (b)(6) 2024 the patient received replacements for external therapy discs due to challenges in maintaining connection between the therapy discs and the implantable pulse generator (ipg).Loss of connectivity results in disruption of therapy.In (b)(6) 2026 the patient underwent surgical revision to correct connectivity issues.On (b)(6) 2026, during the surgical procedure, the ipg displayed only sporadic connectivity with a clinician programmer device as well as the patient's therapy discs.A new ipg was introduced and connected to the existing implanted leads.Intra-operative testing confirmed all good impedances and connectivity with the new ipg and the procedure was successfully completed.

• 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 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50024551
• Report Number: 3015425075-2026-00068
• Device Sequence Number: 10540141
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2026

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: 06/02/2026
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 06/02/2023
• 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