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

Model Number	34003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The nalu representative reported that the patient had been missing for several days of their nalu trial and discovered that the patient was admitted to a care facility via the baker act.And the patient reportedly remains in a medical facility, possibly having also sustained a cardiac event.The nalu trial leads were removed.There is no confirmation of a cardiac event, only patient assertion.Nalu trial leads were removed as designed.
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.The following mdr information is being submitted as part of capa investigation pcar42 remediation activities.There does not appear to be any correlation between the patient's mental status and the nalu trial.There is no confirmation of a cardiac event, only patient assertion.The reported device was not returned for evaluation.Therefore, the root cause cannot be determined.

• 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: 50792854
• Report Number: 3015425075-2026-00499
• Device Sequence Number: 10510437
• Product Code: GZF
• UDI-Device Identifier: 00812537035055
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 34003
• Device Lot Number: 9456248
• 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: 07/22/2025
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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