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	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve simulator system on (b)(6) 2023 to treat bilateral lower back pain.On (b)(6) 2024 the patient called the nalu product support line to report that the nalu system had been explanted on (b)(6) 2024 due to inadequate pain relief.Per the patient, the implanted lead had migrated away from the nerve target, likely causing the lack of pain relief.
Additional Manufacturer Narrative
When reporting the explant, the patient also reported to the nalu team that he exercises in a gym 2 hours every day.Neither the patient nor the physician had notified any nalu representatives of any issue with the system prior to explanting.It is suspected that the patient's physical activity likely played a role in the migration of the system, however this is unable to be confirmed, and 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: 20295538
• Report Number: 3015425075-2024-00357
• Device Sequence Number: 17942080
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: 0100812537035628112203071725030710QJ136
• 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: 2023
• 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): 09/12/2024

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: 03/07/2025
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: QJ136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2022
• 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