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

Model Number 72006

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/04/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 to treat knee pain.In (b)(6) 2023 the patient reported swelling and pain near the implantable pulse generator (ipg) pocket.Lab testing confirmed there was no infection present.Testing of the nalu system at that time found that multiple electrodes on both implanted leads were not functioning as expected.A surgical revision was performed on (b)(6) 2023 to replace the malfunctioning leads as well as placing a new ipg in a new pocket location.

Manufacturer Narrative

The patient reported getting some pain relief while using the nalu system prior to the revision being performed.The explanted components were discarded by the medical facility and thus unavailable for further inspection and investigation to determine the cause of the malfunction.There is no indication of any issue with the ipg and no confirmation of infection.Patient reports no external trauma at the ipg location that would have potentially contributed to the pain.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: 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: 18441452
• MDR Text Key: 331858530
• Report Number: 3015425075-2024-00001
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112210041725100410SR406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: 72006
• Device Catalogue Number: 72006
• Device Lot Number: SR406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other