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

Model Number 71019

Device Problem Malposition of Device (2616)

Patient Problem Discomfort (2330)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Patient reported discomfort began shortly after having the permanent system implanted, indicating a malposition of the leads.There is no allegation or indication of any system or component failure, patient discomfort is from the placement of the device.

Event Description

Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat abdominal pain after having completed a successful trial phase.During a post-operative follow-up visit on (b)(6) 2024 it was noted that the patient was having discomfort from the implanted leads and would require a revision to reposition the lead.Surgical revision was completed on (b)(6) 2024 to place new leads in a position that would be more comfortable for the patient.

• 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: 19047880
• MDR Text Key: 339433986
• Report Number: 3015425075-2024-00119
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411123081617260816
• 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: 04/04/2024

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: Not provided
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other