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

Model Number	71004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient initially displayed signs of poor healing at the incision site, but no reports were received of any signs of infection.Approximately 2 months after the implant, the surgical sites appeared to have healed.It is unclear if there was any event that may have caused the wounds to re-open.The patient's medical history is unknown to the firm and thus unable to determine if there is possibly an underlying condition that may have caused failure to heal.Poor healing is a known risk of surgical procedures.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2024 and as of (b)(6) 2024 the surgical incision sites were reported to have failed to close and heal as expected.An explant was scheduled to take place on (b)(6)2024 due to the failure to heal, however during the pre-op assessment the sites were reported to have fully closed and the explant did not take place and the physician stated the patient would continue to be monitored.On (b)(6)2025 a nalu representative was notified by the physician's office that this patient had undergone an explant on (b)(6)2025 due to ongoing issues with healing.

• 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: 21673428
• Report Number: 3015425075-2025-00107
• Device Sequence Number: 12792106
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)240229(17)270228
• 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): 03/23/2025

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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