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

Model Number	71020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After conducting a post-acquisition, retrospective review of nalu peripheral nerve stimulation complaint records, boston scientific determined that this event meets mdr reporting criteria.This incident is being re-opened/updated per pcar42 remediation activities.\ \ no product was able to be salvaged from this case; therefore, the cause of the reported symptoms could not be determined based on the available information.
Event or Problem Description
The patient was explanted for concerns of poor healing leading to potential risk of infection.The incision site was noted to be slightly open and a dissolvable suture appeared to be working its way to the surface and not being absorbed.The physician stated, no real sign of infection but the chance of potential infection was too great and so explant was warranted.No complaint from patient of infection-like symptoms.

• 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: 50846115
• Report Number: 3015425075-2026-00736
• Device Sequence Number: 9949411
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model 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: 05/20/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown