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

Model Number 71020

Device Problems Fracture (1260); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Prior to the surgical intervention, it appeared that the ipg had been functioning as designed, however migration of the component likely caused some communication issues between the ipg and the external therapy discs, thus leading to inadequate pain relief.Migration of implanted components is a known inherent risk of implantable neuromodulation devices.There are no reports of any external trauma or strenuous activity that would likely cause a fracture to the lead.The information available to the firm does not allow a clear conclusion as to the cause of the lead fracture.

Event Description

Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat knee pain.In (b)(6) 2024 the firm was made aware that the patient had ceased to receive pain relief on the lateral aspect of the knee and was experiencing inadequate pain relief in general to the lower extremity.Investigation found that the implantable pulse generator (ipg) had migrated within the pocket and the lateral lead had fractured.A surgical procedure was initiated on (b)(6) 2024 to replace the fractured lead.During the procedure the ipg was damaged and thus also required replacement.

• 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: 18919265
• MDR Text Key: 337844322
• Report Number: 3015425075-2024-00091
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821123072517260725
• 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: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other