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

Model Number	71007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A nalu representative present at the explant procedure reported that there was no obvious visual damage to the device.The patient is reported to be relatively active and also wears and ankle brace on the right lower extremity.It is unclear if possibly the patient's activity level was inappropriate during the recovery period.Possibly contributing to the device being unstable and disconnecting before the area had fully recovered.It is possible that the lower extremity brace contributed to the event by placing pressure on the device during healing.It is also possible that the device had not been fully connected during the implant procedure, allowing for disconnection during the healing process.A conclusive cause for the device disconnection is unable to be established with the information available.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat right lower extremity pain.When a nalu representative attempted to activate the system during a post-op visit, the patient reported no sensation from the device and testing returned low impedance readings.During the activation, the physician noted some pain and slight redness at the incision site and suspected infection.Physician recommended to explant the system due to the suspected infection.On (b)(6) 2024 the system was explanted and the physician reported no signs of infection upon opening the site.During the explant procedure it was discovered that the implanted lead had become disconnected from the implantable pulse generator (ipg) and that had been the cause of the patient's discomfort at the incision site.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21147626
• Report Number: 3015425075-2025-00024
• Device Sequence Number: 13045206
• Product Code: GZF
• UDI-Device Identifier: 00812537037356
• UDI-Public: (01)00812537037356(11)240607(17)270607
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 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): 01/14/2025

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: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/14/2025
• 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