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

Model Number 72006

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

The nalu system had been in place and functional for more than a year before the patient's symptoms were reported.Imaging confirmed damage to one of the implanted leads and was inconclusive regarding the second lead and the ipg.It is thought that the fall and motor vehicle accident likely caused damage to the implanted components and thus the lack of therapy.

Event Description

Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022 to treat upper extremity pain.In (b)(6) the firm was notified that the patient had sustained a fall and had also been involved in a motor vehicle accident and subsequently the nalu system was not providing pain relief.Testing found that all contacts were out on one lead and three out of four contacts were out on the second lead.Imaging was taken and noted that one of the implanted leads was bent or broken.The second implanted lead was not clearly visible and thus the imaging was inconclusive.It was also observed that the implantable pulse generator (ipg) and the external therapy discs were not consistently maintaining communication.On (b)(6) 2024 the patient underwent surgical revision in which the implantable pulse generator (ipg) and both implanted leads were replaced.

• 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: 19001292
• MDR Text Key: 338881036
• Report Number: 3015425075-2024-00104
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112207111725071110RK954
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: RK954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other