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

Model Number 71019

Device Problem Malposition of Device (2616)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/08/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023.On (b)(6) 2023, the patient underwent a surgical revision to relocate the implantable pulse generator (ipg) to a more superficial location to improve communication between the ipg and the external therapy discs.On (b)(6) 2023, the patient reported the communication issues between the ipg and the therapy discs were persisting, particularly when sitting or laying down.Ultrasound imaging was performed and found the ipg to be within the recommended depth, but with a slight migration within the pocket, causing the ipg to be slightly tilted in relation to the therapy discs.The ipg was also located in a skin fold area.On (b)(6) 2024, a surgical revision was performed to bring the ipg superior, more superficial, and away from any skin folds.Intra-op testing was performed to confirm communication was restored.Xray imaging was also completed to verify placement of the ipg.

Manufacturer Narrative

There is no indication that the nalu system or any of its components failed or malfunctioned.It appears that the placement of the ipg was not optimal with relation to the patient anatomy.Placing the ipg in a location with loose tissue or skin folds allows for shifting of the devices and tissues and leads to issues maintaining communication between devices.

• 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: 18862356
• MDR Text Key: 337182272
• Report Number: 3015425075-2024-00083
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 87 YR