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

Model Number 71005

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Numbness (2415)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

Details around the increased pain and reduced sensation in the lower extremities were not shared with the firm.Exact nature of the spinal surgery and reasoning for the procedure were also not shared with the firm.The nalu system was discarded during the surgery, no imaging was taken prior to explant to confirm placement or condition of the system.Nalu personnel were not made aware of the incident while it was occurring and thus were not present to assess the system.

Event Description

On (b)(6) 2024 the patient was implanted with the nalu spinal cord stimulator system, targeting the lumbar nerve to treat upper back pain.Fluoroscopy imaging was used during the procedure to assure proper placement of the implants in the vicinity of t8-t10.On 22jan2024 the firm was notified of the following incident.On (b)(6) 2024 the patient contacted the implanting physician to report increased pain in the back and loss of feeling in lower extremities.Physician instructed the patient to go to the local emergency department, where the patient was admitted to the acute facility and underwent spinal surgery.The nalu system was explanted 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: 18755133
• MDR Text Key: 335932498
• Report Number: 3015425075-2024-00055
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other