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

Model Number	71019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of implant and activation the patient reported receiving some level of pain relief, however declined to participate in activities to maximize the therapy through troubleshooting and program adjustments.It appears that the nalu system was functioning as expected based on initial feedback from the patient.Unable to fully assess due to patient being unresponsive.The system was explanted and discarded by the medical facility prior to notifying the firm.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 and reported receiving some pain relief but was not satisfied with the level of relief being achieved.Reprogramming was performed in (b)(6) 2022 to attempt to achieve a higher level of relief for the patient.After the reprogramming, the patient became unresponsive.On (b)(6) 2023 a nalu representative received notification that the patient reported to the physician that they were dissatisfied with the level of therapy being received and did not wish to perform any troubleshooting or reprogramming.Patient requested explant.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: 17884852
• Report Number: 3015425075-2023-00237
• Device Sequence Number: 20581645
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: 01008125370356041120120317231203
• 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: 2022
• 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): 10/04/2023

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: 12/03/2023
• Device Model Number: 71019
• Device Catalogue Number: 71019
• 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: 09/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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