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

Model Number	72007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient experienced migration of an implanted lead on one side only within 3 months of implant.There are no reports of any specific events that are likely to have directly contributed to the lead movement and the second lead did not experience migration.Migration of implanted components is a known and inherent risk of implantable neuromodulation devices.
Event or Problem Description
A nalu peripheral nerve stimulator system was implanted on (b)(6) 2025 to treat bilaterl lower back pain.After activating and using the system, the patient reported loss of pain relief on the left side.Imaging found that one of the implanted leads had migrated away from the intended nerve target.A surgical procedure was performed on (b)(6) 2025 to replace the migrated lead.During the procedure the physician also replaced the implantable pulse generator (ipg) and the second lead, despite no problems reported with those components.

• 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: 22493904
• Report Number: 3015425075-2025-00205
• Device Sequence Number: 20879979
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)241106(17)271106(10)9458063
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/08/2025

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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9458063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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