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

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat lower back pain.The implantable pulse generator (ipg) was placed in the lower back area with the implanted leads targeting the cluneal nerve.Shortly after activating the system the patient reported feeling a pop sensation near the implant site and subsequently had pain at the site regardless if the system was activated or not.A full system replacement was performed on (b)(6) 2024.The new ipg was placed back in the same pocket and the leads are targeting the same nerve location.See mdr 3015425075-2024-00299.Approximately one month after replacing the system in (b)(6) 2024, the patient noted some communication issues between the ipg and the external therapy discs.The patient was seen for multiple reprogramming and troubleshooting sessions and ultimately was unable to achieve adequate therapy, leading to a request for device removal.On (b)(6) 2025 a full system explant was performed per the patient's request.
Additional Manufacturer Narrative
During the system explant on (b)(6) 2025 a nalu representative present at the procedure reviewed the pre-explant imaging and noted that the ipg had migrated within the pocket so that the head was rotated away from the skin surface.Migration of the ipg likely affected the communication between the ipg and the therapy discs, causing loss of therapy and thus inadequate pain relief for the patient.There are no reports of any excessive activities or any specific events that may have contributed to ipg migration.The device appears to have migrated almost immediately after implant, based on the communication issues noted within a month of the procedure.It is possible that the ipg was in unstable tissue or that the device was not sutured sufficiently to prevent movement.Cause of device migration is unable to be conclusively determined with the information available to the firm.

• 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: 22147195
• Report Number: 3015425075-2025-00181
• Device Sequence Number: 7849172
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240110(17)270110
• 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: 2024
• 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): 06/04/2025

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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