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

Model Number 72003

Device Problem Failure to Advance (2524)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Patient has a history of other failed surgical interventions which the patient reports are due to scar tissue.Medical records for those failed attempts are not available to the nalu firm for review and confirmation.Patient is reported to have a congenitally narrow canal and likely significant spinal stenosis, making entry and placement of the nalu leads difficult and leading to the procedure being aborted.There are no reports from the implanting physician of any surgical tool failure or nalu system or component failure.

Event Description

On (b)(6) 2023 a surgical procedure was attempted and aborted.Patient was scheduled to receive the nalu spinal cord stimulator trial system implanted, however upon attempting to insert the leads the physician found he was unable to insert the leads past the t10 vertebra.Physician attempted entry at l1/2 and moved up to t12/l1 also with no success.Physician injected contrast dye into the epidural space and was not able to achieve any flow upward or laterally.Ultimately the physician elected to abort the procedure without placing the system.

• 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: 18416537
• MDR Text Key: 331577711
• Report Number: 3015425075-2023-00322
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112211031725110310UF534
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: UF534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other