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

Model Number	72006
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is likely that the open circuit impedance error on the implanted lead is related to the connector between the lead and ipg.Disconnecting the lead allowed for the end of the lead to be wiped and assured to be clear of any fluids before reconnecting to the ipg and thus clearing any obstruction and allowing a full circuit to be re-established.All original components remain implanted and in use and the patient is reporting good therapy from the system.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat knee pain.The patient completed several surveys after implanting the system and consistently reported reduction in pain symptoms by approximately 50%.One such survey was completed by the patient on (b)(6) 2025 and reported pain levels at 3/10.On (b)(6) 2025 the patient was seen in the medical clinic and a nalu representative present discovered impedance errors on the patient's medial lead.Imaging was performed on (b)(6) 2025 and does not appear to show any damage or migration of the implanted leads.The patient continued to report receiving good pain relief, however requested interventions to correct the impedance error and optimize therapy.On (b)(6) 2025 a surgical intervention was performed in which the malfunctioning lead was repositioned and reconnected to the implantable pulse generator (ipg).After reconnecting the lead, all testing returned good readings and the patient reported receiving good therapy.

• 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: 22768332
• Report Number: 3015425075-2025-00249
• Device Sequence Number: 21228829
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: (01)00812537037370(11)240806(17)270806(10)9457613
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/10/2025

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9457613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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