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 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The initial lead fracture occurred after the patient sustained a fall and it is thought the external trauma caused the lead to fracture.The cause of the second lead fracture is unknown as the patient reports no further instances of falls or trauma.Patient also reports no excessive activity that could potentially lead to a lead fracture.

Event Description

Patient was implanted with a nalu peripheral nerve stimulation system on (b)(6) 2022 for knee pain.While performing an impedance check for an upcoming mri, it was noted that the lateral lead was fractured.Patient underwent a revision procedure on (b)(6) 2023 to replace the fractured lead (see mdr 3015425075-2023-00271).Only a single implanted lead was replaced during that revision, the implantable pulse generator (ipg) remained in place and the system was in use for approximately three months.Patient was seen on (b)(6) 2024 for a reprogramming session and reported that there was no sensation of stimulation on the lateral knee for the previous 2-3 weeks.Imaging was performed at the clinic and was inconclusive, however a fracture of the lateral lead was suspected.On (b)(6) 2024 a second surgical revision was performed to replace the lateral lead.

• 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: 19001253
• MDR Text Key: 338880909
• Report Number: 3015425075-2024-00103
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036335
• UDI-Public: 0100812537036335112207111725071110RK955
• 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: RK955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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