MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number 71005

Device Problems Fracture (1260); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported cessation of therapy occurred after sustaining multiple falls.The system had been in use for more than a year with no apparent issues prior to the falls.It is likely that the external trauma directly affected the implanted system and led to the fracture and migration of the leads.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2022.Patient had reported receiving good therapy from the system after implant.In (b)(6) 2023 the patient reported having sustained multiple falls and subsequent loss of pain relief from the nalu system.Imaging and impedance checks determined that one of the implanted leads had fractured and the other implanted lead had migrated away from the target area for pain relief.On (b)(6) 2023 a surgical revision was performed in which all of the implanted components were replaced and new components were implanted at the target location.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18461075
• MDR Text Key: 332252695
• Report Number: 3015425075-2024-00009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001122041917250419
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other