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	Implant Pain (4561)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was unclear during reporting if any cultures were taken of the incision site while being seen at the hospital on (b)(6) 2025.The patient also reported during the communication on (b)(6) 2025 that there was a daily exercise routine that included gym workout and walking 2-4 miles.Although the patient had reported symptoms of potential infection, there are no known lab results to confirm presence or type of infection at the implant site.Additionally, it is unclear how the patient's daily exercise regimen and associated hygiene may have affected healing.
Event or Problem Description
The patient was initially implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat abdominal pain.After activating the system it was discovered that the implant location did not provide adequate tissue quality to support stability of the implantable pulse generator (ipg) and on (b)(6) 2025 the ipg was removed and a new one was placed in a new pocket location.See mdr 3015425075-2025-00343 on (b)(6) 2025 the patient contacted the firm to report onset of pain at the implant site, including swelling and redness.During the conversation the patient disclosed having experienced extreme pain at the implant location on (b)(6) 2025 for which the patient reported having been seen at a local hospital and given morphine to address.Patient was advised to contact the medical doctor for follow up.On (b)(6) 2026 a full system explant was performed due to the reported symptoms.

• 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: 24341651
• Report Number: 3015425075-2025-00379
• Device Sequence Number: 9674054
• Product Code: GZF
• UDI-Device Identifier: 00812537037349
• UDI-Public: (01)00812537037349(11)250227(17)280227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/15/2026

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: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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