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

Model Number	71019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported feeling tonic sensation in the location being targeted, thus confirming no migration or fracture of leads.All system testing returned normal results.There does not appear to be any malfunction or failure of the nalu system.Patient requested explant less than 30 days after being implanted and with no notification to nalu.Inability to achieve full pain relief is a known risk of neuromodulation systems.
Event or Problem Description
Patient came to nalu after a trial implant from a different neuromodulation device manufacturer.The nalu peripheral nerve stimulator system was implanted on (b)(6) 2023.After the implant the patient reported feeling tonic sensation in the desired location and all system testing returned normal results, however the patient reported dissatisfaction with the level of pain relief being attained.Multiple attempts were made to troubleshoot and reprogram in order to achieve additional pain relief for the patient.Patient requested to have the system removed due to inability to achieve the desired effects from the system.Full system was explanted on (b)(6) 2023.Nalu was not made aware of the explant procedure until (b)(6) 2023, thus no representatives were present at the procedure and were unable to obtain the explanted device for testing.

• 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: 17608518
• Report Number: 3015425075-2023-00224
• Device Sequence Number: 17997200
• Product Code: GZF
• UDI-Device Identifier: 00812537035598
• UDI-Public: 01008125370355981119111417221114
• 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: 2023
• 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): 08/23/2023

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: 11/14/2022
• Device Model Number: 71019
• Device Catalogue Number: 71019
• Device Lot Number: A00471
• 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: 08/16/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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