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

Model Number	72002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no allegations or indications of any system or component failure or malfunction.The positioning of the implanted components appears to have been pressing against the skin and contributing to a failure of the incision site to fully heal.The initial signs of infection are reported approximately 6 months after the initial implant, making it unlikely that the nalu device itself was the source of the infection.Improper healing and infection are known inherent risks of surgical procedures and in this case it appears that the placement of the implanted components contributed to the poor healing.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.The patient reported significant improvement in pain symptoms with use of the nalu system, however the surgical incision site failed to properly heal due to the lead pressing against the incision.The physician attempted to close the wound but was unsuccessful and eventually noted visible signs of infection at the incision site.On (b)(6) 2025 a surgical revision was performed to remove the ipg from its original position and place a new ipg in a different pocked location as well as placing new leads that were positioned to lay flat under the skin surface and avoid pressure on the incision.See mdr 3015425075-2025-00089.Approximately 1 week after the revision, the new system was activated and the patient again reported good pain relief.On (b)(6) 2025 a nalu representative was notified that the patient was being scheduled to remove the nalu system.Per the patient and spouse, the incision site continues to drain and show signs of infection.On (b)(6) 2025 a full system explant was performed.Nalu personnel were not notified of the procedure ahead of time and thus unable to attend.

• 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: 21669765
• Report Number: 3015425075-2025-00090
• Device Sequence Number: 8164871
• Product Code: GZF
• UDI-Device Identifier: 00812537033624
• UDI-Public: (01)00812537033624(11)231113(17)261113(10)9455983
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/21/2025

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: 72002
• Device Catalogue Number: 72002
• Device Lot Number: 9455983
• 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: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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