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

Model Number 71019

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/23/2023

Event Type  Injury  

Event Description

Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat lower back pain after having successfully completed a trial phase.After having the system activated the patient reported communication issues between the implantable pulse generator (ipg) and the external therapy discs when sitting or laying in specific positions.Patient also reported that the location of the device was awkward with certain items of clothing.Patient was reporting good pain relief when the system was connected.On (b)(6) 2023 a surgical procedure was performed to place a new ipg in a slightly higher and flatter area of the back to maintain more consistent communication with the therapy discs and not interfere with the patient's clothing.The original ipg was retained by the facility per their protocol and is not available for review by the firm.

Manufacturer Narrative

There are no allegations of system or component failure or malfunction and no indications that migration occurred after implant.The anatomical location chosen for the ipg placement was an area with skin and tissue movement when the patient changed positions and caused the devices to move in a way that interfered with communication.

• 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: 18188708
• MDR Text Key: 328735369
• Report Number: 3015425075-2023-00287
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411123071017260710
• 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: 11/21/2023

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other