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

Model Number	71019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of records found no communication from the patient or medical staff between august 2022 and april 2025 to indicate any complaints or issues with the nalu system or it's function for this patient.The patient did not share any further details around the reason for the explant beyond stating that the system was no longer being used.It is unclear if the system was providing inadequate therapy or if the patient's pain symptoms had decreased, making the system no longer needed.The explanted components were not returned to the firm for evaluation and thus no further investigation is able to be performed in determining device functionality.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022 after having completed a successful trial and wear study with nalu.On (b)(6) 2022 the patient reported connectivity issues between the implantable pulse generator (ipg) and the external therapy disc.Xray imaging found that the ipg had migrated within the pocket, causing the communication issues.Additionally, one of the implanted leads was found to have migrated out of position.The decision was made to remove the system and implant a new one in a slightly different location in order to provide a more optimal connection based on the patient's skin and fat anatomy.The revision procedure took place on (b)(6) 2022.See mdr 3015425075-2022-00042.During a follow up visit with the physician on (b)(6) 2022 it was noted that the patient had incisional dehiscence, exposing the lead wire.Pocket revision and wound closure was performed on (b)(6) 2022 and the patient resumed pain relief therapy.See mdr 3015425075-2022-00058.No further complaints or issues are documented for this patient after the wound closure in (b)(6) 2022 until the firm was notified in (b)(6) 2025 that the patient is no longer using the nalu system and requested explant.A full system explant was performed on (b)(6) 2025 per the patient's request.

• 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: 21982146
• Report Number: 3015425075-2025-00157
• Device Sequence Number: 17262853
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: (01)00812537035604(11)201021(17)231021
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/07/2025

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 Expiration Date: 10/21/2023
• Device Model Number: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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