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

Model Number	74001
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The nalu sales representative (rep) reported that the patient said that he's having issues with his therapy disc (td), that the amplitude settings are changing and giving him shocks.No further information was provided.There was no reported patient harm or 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.The following mdr information is being submitted as part of capa investigation pcar42 remediation activities.The therapy disc was returned for evaluation.The td passed ate and did not show signs of magnetization or increased rf power.Evaluation was unable to reproduce the reported amplitude and shock issue; therefore, the root cause of the reported event could not 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 -724
• 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: 50839514
• Report Number: 3015425075-2026-00698
• Device Sequence Number: 21349637
• Product Code: GZF
• UDI-Device Identifier: 00812537035444
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 74001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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
• Patient Sex: Male