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

Model Number 72006

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

There are no allegations of system or component failure.The choice of which leads to use for the permanent implant as well as the placement of those leads likely played a significant role in the outcome of the patient's therapy.The explanted system was not made available to the firm for further inspection and testing, however there are no indications of malfunction.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator on (b)(6) 2023 targeting the sural nerve to treat foot pain.The patient underwent a successful trial phase prior to having a permanent implant, however the patient reported not getting the same level of relief from the permanent system as was felt with the trial system.It was noted that the trial system used slightly different leads and that the permanent system leads were not placed in the exact same location as the trial leads.Patient requested to replace the permanent leads to more closely match the trial leads.Physician recommended fully explanting the system, allow healing, then placing a new system targeting a slightly different nerve area.Full system explant took place on (b)(6) 2023.

• 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: 18253063
• MDR Text Key: 329550873
• Report Number: 3015425075-2023-00299
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112207181725071810RK958
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72006
• Device Catalogue Number: 72006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other