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

Model Number	71020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was previously implanted with a nalu peripheral nerve stimulator system on (b)(6)2023.In (b)(6) 2023 the patient reported to the physician that one of the implanted leads was exposed through the skin at the surgical incision site.On (b)(6)2023 the incision was opened and the lead was placed back into a deeper position.During the procedure the site was washed and packed with antibiotic before re-closing.There were no indications of infection based on visual assessment and no lab test were done to determine presence of infection at the site.There were no reports of trauma or other external factors that would lead to the incident.All implanted components remained implanted and in use and the site appeared to have fully healed.See mdr 3015425075-2024-00008.In (b)(6) 2025 the patient again reported to a nalu representative that one lead was pushing through the incision site.Patient provided a picture showing a clear dehiscence of the surgical site and exposed lead.The physician was notified and advised the patient to go to the local emergency department for evaluation and possible immediate explant.Patient declined to follow medical advice and did not go to be evaluated.A regular clinic appointment was attended by the patient and implanting physician on (b)(6)2025 and the physician determined that the system should be explanted.During that visit, the physician used suture removal tools to remove the accessible portion of the device through the dehisched wound site while using local anesthetic in the clinic.The tined lead was unable to be removed at that time and an explant was scheduled.On (b)(6)2025 a surgical explant was performed to remove the tined lead, however the surgeon was unable to successfully remove all of the component.On (b)(6)2025 a second surgical procedure was performed to fully remove all remaining fragments of the nalu system.
Additional Manufacturer Narrative
There are no known cultures or other lab testing to confirm or rule out infection, however the visual assessment of the dehisced wound does not show any clear signs of infection.The patient has a very high bmi and poor skin and tissue quality at the extremity where the nalu device was implanted.There are mobility issues and it is unknown if possibly there was some rubbing or other external factors that may have contributed to the skin erosion.It is also possible that the patient's body is rejecting the implant as there is a prior history of implanted components being exposed through the skin.Ultimately, the cause of the dehiscence of the surgical site is unknown.

• 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: 21728556
• Report Number: 3015425075-2025-00104
• Device Sequence Number: 15801385
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)220623(17)250623
• 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: 2023
• 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): 03/29/2025

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 Expiration Date: 06/23/2025
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• 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