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

Model Number	72011
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is likely that during the initial revision in (b)(6) 2024, the implanted lead was placed slightly away from the intended nerve target, causing therapy to not reach the desired pain location.There is no indication of any system or component failure and no components required replacement during the (b)(6) 2025 repositioning procedure.It is likely that repositioning the leads a second time still did not accurately place the device to provide optimal therapy coverage of the areas of pain, leading to the patient request for explant of the system.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 with the implantable pulse generator (ipg) being placed in the lower back area.After activating the system, the patient noted that the shifting body positions would cause disruptions in communication between the ipg and the external therapy discs, leading to intermittent pain relief.Xray imaging found that, in addition to the communication issues, both implanted leads had also migrated away from the optimal placement.On (b)(6) 2024 a surgical revision was performed to place a new ipg at a less dynamic location of the back and to place new leads back at the desired location.See mdr 3015425075-2024-00413.After activating the revised system, the patient noted that the superior cluneal lead was only getting coverage in the hip area and not addressing the lower back pain.On (b)(6) 2025 a surgical revision was performed to open up the site and pull the lead to a more medial position to better cover the lower back pain.No product was removed or replaced and no new implants were introduced during this procedure.See mdr 3015425075-2025-00085.In (b)(6) 2025 the patient reported still not receiving the desired level of pain relief from the system and requested to remove it.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: 22180553
• Report Number: 3015425075-2025-00180
• Device Sequence Number: 15887627
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: (01)00812537035628(11)230918(17)260918(10)9455526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2025

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: 09/18/2025
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 9455526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• 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