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	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There have been no lab cultures shared with the firm to confirm or rule out presence of any type of infection at the surgical sites or anywhere else.There are no reports of any concerns around the patient's wound care compliance or potential events that may have contributed to surgical site dehiscence.The patient has history of two different surgical sites appearing to heal and then later re-opening, ultimately leading to surgical intervention being required.Cause of the wound issues is unknown and the information available does not allow any conclusions to be drawn.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2025 to treat knee pain.Approximately 1 month after the implant the system was discovered to have open circuit readings due to a fracture of the lateral lead.On (b)(6) 2025 the fractured lead was replaced.After replacing the lead, the patient experienced challenges in wound healing at the surgical site, including skin erosion around the site of the implantable pulse generator (ipg).On (b)(6) 2025 the implanted components were removed and new components were placed in a different location.The new implant site appeared to have been healing well, however at the 3 month post-op visit on (b)(6) 2025 the medical team discovered that the new surgical site that had been healing had then dehisced and was showing signs of possible infection.The patient was given oral antibiotics and on (b)(6) 2026 the nalu system was fully removed.

• 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: 24754287
• Report Number: 3015425075-2025-00368
• Device Sequence Number: 15728596
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)250506(17)280506
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/04/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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