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	Unspecified Infection (1930)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The infection was not confirmed through lab cultures and the firm was informed that lab cultures that were performed had no growth.Infection diagnosis was based on visual assessment and symptoms only.Initial reports of infection were received more than 6 months after the last nalu related surgical procedure, thus indicating that the nalu device is unlikely to have been the source of the infection.The patient reported being unable to bathe and it appears that personal hygiene played a direct role in the symptoms reported.Review of records between (b)(6) 2024 and (b)(6) 2025 found no complaints regarding the nalu system or any associated components.It appears the system was functioning as expected and delivering therapy and the reason for explant is the suspected infection.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 with the implantable pulse generator (ipg) placed in the anterior thigh area.On (b)(6) 2024 a revision procedure was performed to move the existing ipg to a more superficial location to improve communication.No components were replaced during the procedure and all original components remain implanted and in use (see incident 3549).After the revision procedure, the patient had reported no further complaints or issues until after having a pacemaker implanted.Date of the pacemaker implant is unknown.During the healing process after pacemaker implant, the patient was unable to shower and thus developed a localized skin infection at the site of the adhesive nalu clip.Patient was placed on antibiotics, which were not successful in clearing the suspected infection.Later assessment by the physician found that the symptoms were progressing and it was suspected that the nalu implant was becoming involved and required explant.A full system explant was performed on (b)(6) 2025 due to expanding symptoms from suspected infection.

• 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: 22343160
• Report Number: 3015425075-2025-00189
• Device Sequence Number: 8512876
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240123(17)270123
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/26/2025

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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