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

Model Number	72003
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The nalu representative (rep) reported that during the trial implantation, after the first lead was placed at the sciatic nerve, the patient did not feel paresthesia in the region of her pain.A second lead was placed at the common peroneal nerve, and the patient was discharged to the recovery room.At this time, the patient still did not achieve paresthesia in the region of her pain, and the plan was to attempt to achieve this with programming.Ultimately, the patient reported paresthesia in the region of her pain after programming, although she was reporting post-procedure pain at this time.The nurse dressed the area and provided thorough wound care instructions.At the time the patient was discharged, and it was our understanding that she was achieving paresthesia in the region of her pain.Two hours later, the patient reported severe pain that was affecting her ability to walk and was unwilling to return to the study site at that time because she was already an hour away.The patient felt at that time that her pain was attributed to the lead at the sciatic nerve.She was provided with instructions on removing the sciatic lead by the physician.After this conversation, there was no communication from the patient.The patient had removed the second lead due to discomfort.
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.The implanted trial leads are designed and intended to be removed as part of the normal trial process.The removal of the leads is normally performed in a clinical setting, however in this case the patient was able to remove them independently with instructions from the implanting physician.The patient did not report any ongoing pain or physical issues after removing the trial leads.The patient reported no signs of infection at the surgical incision site.The device was discarded by the patient and not available for evaluation.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: 50872338
• Report Number: 3015425075-2026-00640
• Device Sequence Number: 18827151
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Expiration Date: 03/09/2026
• Device Model Number: 72003
• Device Lot Number: UF572
• 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: 08/10/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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: Female