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

Model Number 72006

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

The explanted components were discarded by the medical facility and thus not available for inspection by the firm.The information available does not suggest any failure or malfunction of the nalu system.There is no indication that the implanted components were improperly positioned in a manner that would cause pain symptoms.There is insufficient information available to draw any conclusions as to the cause of the patient's new pain symptom.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 after a successful trial phase.On (b)(6) 2023 the patient reported to the firm that after using the system for approximately three weeks, the original pain location being treated was responding well to the therapy, but a new pain location was identified above the location where the nalu leads were implanted.The nalu system was completely turned off, however the patient reported ongoing pain that was exacerbated with movement.A full system explant was performed 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: 18036027
• MDR Text Key: 326907000
• Report Number: 3015425075-2023-00261
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112204281725042810QJ122
• 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: 10/30/2023

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: 72006
• Device Catalogue Number: 72006
• Device Lot Number: QJ122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other