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

Model Number 72003

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

There is no evidence of device or system failure.The lack of neural response appears to be related to the positioning of the implanted components.

Event Description

Patient began the trial phase for the nalu peripheral nerve stimulator on (b)(6)2023.After implanting the trial leads the patient was unable to get any neural response from the system.The intention was to target the suprascapular nerve, however it was suspected that the leads were floating above the suprascapular fossa instead of hitting the desired location.A surgical revision was performed on (b)(6)2023 to remove the implanted trial leads and replace with a new set of leads targetting the desired nerve location.The trial was completed successfully and the leads were removed as planned on (b)(6)2023.Patient is preparing for permanent implant procedure.

• 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: 17917438
• MDR Text Key: 325444367
• Report Number: 3015425075-2023-00241
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112301241726012410UF564
• 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: 10/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other