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

Model Number 71005

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 01/24/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2022 to treat lower back pain.Patient underwent a successful trial phase prior to implanting the permanent device and in (b)(6) 2023 the patient reported significant reduction in pain, however there was a persistent discomfort at the location of the implant.In (b)(6) 2023 the patient reported lack of pain relief and ongoing discomfort at the site of the implant.Multiple attempts at troubleshooting and reprogramming were attempted and unsuccessful.Patient ultimately requested to remove the system.A full explant was performed on (b)(6) 2024.

Manufacturer Narrative

There are no reports of any obvious external factors that would contribute to lack of pain relief and the system appears to be functioning as expected during reprogramming sessions.No imaging was done prior to explant to confirm placement of the implanted components.The explanted device was held by the medical facility and is not available for further testing by the firm.

• 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
• 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: 18773879
• MDR Text Key: 336182879
• Report Number: 3015425075-2024-00058
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other