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

Model Number	71019
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nalu system was implanted and in use for 3 years before the communication issues were reported.There are no reports of any external trauma or other events that are likely to have led to device migration.Migration of components is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2021 and reported improvement in pain symptoms.In (b)(6) 2024 the patient noted some issues with communication between the implantable pulse generator (ipg) and the external therapy discs, resulting in inadequate pain relief for the patient.Imaging found that the ipg had migrated within the pocket and was no longer in the appropriate position to achieve optimal communication.Patient requested to remove the system.A full system explant was performed on (b)(6) 2024 per patient 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 20578886
• Report Number: 3015425075-2024-00402
• Device Sequence Number: 8171053
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: 01008125370356041120120417211204
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 10/31/2024

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: 12/04/2021
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2020
• 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