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

Model Number	72011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 after participating in a successful trial phase with nalu.The system was implanted near the lateral shoulder with the leads targeting the suprascapular nerve to treat shoulder pain.During the trial the patient had reported receiving good pain relief, however the patient noted that the same therapy was not being felt with the permanent system.Imaging was performed and found that one of the implanted leads had migrated away from the intended nerve target, thus causing the inadequate pain relief.On (b)(6) 2025 a surgical procedure was performed to reposition the lead back to the intended position to regain therapy.No components were removed or replaced during the procedure and no new components were introducted.All original system components remain implanted and in use.
Additional Manufacturer Narrative
Nalu field personnel working with this patient report that the implanting physician has a history of excellent anchoring techniques and that there is no obvious event or issue that may have caused or contributed to the device moving.Migration is a known inherent risk of implantable neuromodulation systems.

• 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: 21417182
• Report Number: 3015425075-2025-00057
• Device Sequence Number: 20770221
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: (01)00812537035628(11)240111(17)270111(10)9456392
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/14/2025

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: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 9456392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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