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

Model Number 71020

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

Migration is a known inherent risk of implantable neuromodulation devices, however, in this case the migration appears to be directly related to the physical symptoms from the patient experiencing a severe vomiting episode.No components were replaced during the procedure and the system remains in use.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 targeting the ilioinguinal nerve to treat pelvic pain.Patient reported 100% pain relief after being implanted.Approximately 10 months after implant the patient reported becoming violently ill, including vomiting.After becoming ill, the patient reported onset of difficulty maintaining communication between the implantable pulse generator (ipg) and the external therapy discs.A surgical revision was performed on (b)(6) 2023 to reposition the ipg to a more superficial position and correct the communication issues.

• 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: 18235224
• MDR Text Key: 329314141
• Report Number: 3015425075-2023-00294
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821121072417240724
• 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: 11/29/2023

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other