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

Model Number	72006
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implanted leads used during this patient's trial are a different model than the leads used with the permanent system implant.Most likely cause of the inadequate pain relief is that the slightly smaller leads were not placed at the exact same target location as the larger trial leads, thus causing a different therapy sensation and patient displeasure.Prior to explant the system appeared to be functioning as designed and there was no indication of any component failure.The entire system was discarded during the explant and thus not available for any further testing by the firm.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2021 after a successful trial phase.After being implanted with the permanent system the patient reported not receiving the same pain relief as the trial and is not satisfied with the results of reprogramming the system.Patient refused further programming and requested the system be removed.A full system explant was performed on (b)(6) 2023.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18490066
• Report Number: 3015425075-2024-00013
• Device Sequence Number: 7188336
• Product Code: GZF
• UDI-Device Identifier: 00812537031057
• UDI-Public: 0100812537031057112009011721090110KX345
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 72006
• Device Catalogue Number: 72006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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