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

Model Number	71003
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's spouse managed use of the device for approximately 2 years.Review of records for the 2 years found no prior complaints on file regarding the nalu system or any of its components.At the time of this mdr filing, the device has been returned to the firm post-explant and is pending further testing to confirm if there is any device malfunction that may have contributed to the loss of pain relief for the patient.Primary reason for explant appears to be related to mri conditionality.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator (pns)system on (b)(6)2022 to treat shoulder pain.The patient had a pre-existing scs system from a different manufacturer in place to treat low back and leg pain prior to implanting the nalu pns system, in (b)(6)2023 the patient's spouse called nalu to inquire about mri conditionality and reported that the nalu system had not been in use for several months due to loss of efficacy.Spouse was advised that the patient was not conditional for any mri due to use of dual systems, regardless of system use.On (b)(6)2024 the nalu system was explanted due to mri compatibility.

• 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: 21074806
• Report Number: 3015425075-2025-00002
• Device Sequence Number: 6916622
• Product Code: GZF
• UDI-Device Identifier: 00812537033587
• UDI-Public: (01)00812537033587(11)210719(17)240719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/03/2025

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: 07/19/2024
• Device Model Number: 71003
• Device Catalogue Number: 71003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2021
• 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