MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71019
Medical Device Problem Codes	Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the patient indicates that the most likely sequence of events was that the reported pulling when sitting on the toilet was an indication of the lead being placed under strain during that movement, leading to damage at either the lead or lead connector, resulting in the open circuit impedance reading.That event also likely dislodged the tined lead and allowed it to migrate, resulting in need for surgical intervention.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2025.In (b)(6)2025 the patient reported feeling a pulling sensation when sitting down onto a toilet and thought it was possibly the nalu lead.After that event the system was assessed and found to have open circuit impedance readings on that suspected lead.The system was reprogrammed to work around the affected contact on that lead and the patient reported good therapy at appropriate location.After that reprogramming session, the patient reported decrease in therapy.Field assessment by the implanting physician determined that the lead had migrated away from the intended nerve target.On (b)(6)2025 a surgical procedure was performed to remove the affected lead and place a new lead at the target nerve location.During the procedure the implantable pulse generator (ipg) and second lead were also replaced to avoid potential handling damage.

• 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 7241
• Manufacturer Contact: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 23275760
• Report Number: 3015425075-2025-00295
• Device Sequence Number: 15714915
• Product Code: GZF
• UDI-Device Identifier: 00812537037196
• UDI-Public: (01)00812537037196(11)240607(17)270607
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2025

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 Model Number: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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