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

Model Number 71020

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Pain Relief (2388); Post Operative Wound Infection (2446)

Event Date 07/23/2023

Event Type  Injury  

Manufacturer Narrative

There are no allegations of system or component failure.Malposition of the implanted leads is related to physician technique in performing the implant and attempting to place the implanted components in a comfortable location for the patient.Review of applicable device history records did not identify any excursions that are likely to have contributed to infection.Infection is a known inherent risk of invasive procedures.

Event Description

Patient presented with a preexisting neuroma at the knee where the nalu system was planned for implant.During the trial phase of the implant the patient reported that the implanted components were causing some discomfort at the neuroma.When the patient was implanted with the permanent peripheral nerve stimulator system the physician chose a slightly different location for implant in order to avoid discomfort at the neuroma location.During initial programming the patient reported feeling stimulation in a different area than was targeted and conclusion by the medical staff was that the placement of the implanted leads was improper.On (b)(6) 2023 the patient notified medical staff that they had been seen in an urgent care facility with a diagnosis of infection at the surgical site.A full system explant was performed on (b)(6) 2023 due to combination of suboptimal lead placement and infection.

• 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: 17600555
• MDR Text Key: 321712335
• Report Number: 3015425075-2023-00190
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122030117250301
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Device Lot Number: A03605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other