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

Model Number 71020

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

There is no clear reasoning given for the request for explant.The nalu representative initially working with this patient is no longer with the firm.When current local representatives reached out to the patient, it appeared that the spouse is handling the medical decisions for the patient.Spouse reported difficulty with obtaining reprogramming, however there are no records of the patient or family contacting the firm.The reason for reprogramming was not shared with the current staff.The device was discarded by the medical facility at the time of explant and thus is not available for inspection and confirmation of functionality.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 and reported receiving good relief after the implant.In january 2024 the firm was notified that the patient was scheduled for explant.Upon reaching out to the patient, it was discovered that the patient needed reprogramming and were unclear on how to proceed, thus the patient's spouse chose to just remove the system.Patient's spouse was offered a meeting with a local nalu representative for any programming and troubleshooting needed, the offer was declined.A full system explant was performed on (b)(6) 2024.

• 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 CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18755129
• MDR Text Key: 335932735
• Report Number: 3015425075-2024-00054
• Device Sequence Number: 1
• Product Code: GZF
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other