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

Model Number 71005

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

There are no indications of any device or component failure or malfunction, as evidenced by all components remaining in use.Intra-op testing was conducted during the initial implant procedure and returned good results and complaints of communication issues were received several months after the implant, thus seeming to indicate that the initial placement of the device was appropriate.There are no reports of any external trauma, strenuous activity, or significant weight changes that would likely lead to the symptoms experienced.Any imaging performed prior to the revision has not been made available to the firm for review to confirm depth and placement of the implanted components.Most likely cause of the communication issues is migration of the ipg, which is a known inherent risk of implantable neuromodulation systems.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2022 to treat back pain.In (b)(6) 2023 the patient reported issues maintaining communication between the implantable pulse generator (ipg) and the external therapy discs, causing loss of therapy and inadequate pain relief.Reprogramming and troubleshooting was performed on (b)(6) 2023 and noted that the communication issues were exacerbated with specific movements by the patient.Troubleshooting appeared to resolve the issue at the time, however the firm was notified on (b)(6) 2024 that the patient was scheduled for surgical revision due to ongoing communication issues.On (b)(6) 2024 a surgical procedure was performed to move the existing ipg to a more optimal position.No components were explanted or replaced during the procedure.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18774937
• MDR Text Key: 336175916
• Report Number: 3015425075-2024-00063
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other