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

Model Number	71020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no indications of any system or component failure or malfunction.It appears the patient's experience with failing adhesive clips is directly related to the implant location of the ipg and not due to any issue with the clips themselves.The subsequent development of a hematoma is not associated with the presence of any type of infection and is not associated with any known events or trauma that took place after the implant was repositioned.There is insufficient information available to draw any conclusions regarding cause of the development of a hematoma at the implant site.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to target the sciatic nerve.After activating the system, the patient reported ongoing issues with maintaining the external devices.Specifically, the adhesive clips used to hold the therapy discs in place over the implant were not staying adhered to the skin and allowing the therapy discs to fall off.Troubleshooting was not able to resolve the issue and ultimately it was found that the superficial placement of the implantable pulse generator was causing the implant to press against the underside of the skin and sit proud above the normal skin surface.The protruding device was causing an uneven surface for the adhesive clips, which led to adhesive clip failure.On (b)(6) 2026 a surgical revision was performed to move the existing ipg to a slightly deeper position so that there was no pressure upward against the skin surface.On (b)(6) 2026 the patient reached out to a nalu representative to inform that the incision site had become swollen and the patient had gone to the local emergency department for evaluation.After speaking with the physician assistant at the acute facility, it was discovered that the patient had developed a hematoma at the implant site and had undergone surgical debridement on (b)(6) 2026.After the debridement, the pa reassessed the site and determined that an explant would be needed to allow the location to fully heal.On (b)(6) 2026 a full system explant was performed.

• 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: 24554247
• Report Number: 3015425075-2026-00026
• Device Sequence Number: 9331080
• Product Code: GZF
• UDI-Device Identifier: 00812537037363
• UDI-Public: (01)00812537037363(11)250328(17)280328
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/09/2026

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 Expiration Date: 03/28/2025
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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