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	Unspecified Infection (1930)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nalu peripheral nerve stimulator system was implanted on (b)(6) 2025 with the implantable pulse generator (ipg) being placed in the lower back area and leads targeting the cluneal nerve.Two months after the implant procedure, the patient notified a nalu representative that they had experienced fever/chills and noted the implant incision site was reddened.The patient presented at a local emergency department on the evening of (b)(6) 2025 and was found to have developed an abscess under the incision site.The patient was administered iv antibiotics and a full system explant was performed on (b)(6) 2025.The patient was discharged home with oral antibiotics.
Additional Manufacturer Narrative
Based on the time frame, it is possible but unlikely that the nalu device or the surgical process were the source of the infection.It is more likely that bacteria entered the incision site at some point after the procedure either due to improper wound care or poor hygiene.Although it is unlikely that the infection was caused by the nalu device, an mdr is being filed out of an abundance of caution due to the unknown source of 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: 22493902
• Report Number: 3015425075-2025-00207
• Device Sequence Number: 8188237
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)250103(17)280103
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 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): 07/08/2025

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: 06/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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