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	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was unaware of any changes to therapy and thus was unable to provide any timeline for lead malfunction or events leading up to the malfunction.The impedance errors noted generally indicate open circuit, indicating the likelihood of a fracture within the lead itself or at the connector between the lead and ipg.The explanted devices were not returned to the firm for further investigation into the source of the impedance errors.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat knee pain.In (b)(6) 2025 the patient reached out to a local nalu representative for assistance with syncing a new phone with the nalu remote application.While assisting with the sync process, the system was assessed and found to have impedance errors on one of the leads.The patient had not noted any change in therapy and was fully unaware of any issues.Imaging was performed and showed no obvious issues with the implanted components.Although the patient had not noted any issues with therapy, the physician elected to replace the malfunctioning lead.On (b)(6) 2025 a surgical revision was performed to remove the malfunctioning lead and place a new lead.During the procedure the ipg was also replaced out of caution.During the revision procedure the physician placed pressure on the lead while attempting to remove it and the lead fractured just proximal to the tined end.The procedure included dissecting down to remove the remaining portion of the lead that had separated.

• 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: 23306108
• Report Number: 3015425075-2025-00300
• Device Sequence Number: 5789051
• 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
• 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): 10/15/2025

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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• 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