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

Model Number 72003

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 12/21/2022

Event Type  Injury  

Manufacturer Narrative

Surgical procedure was aborted and patient was deemed to not be a viable candidate for the nalu system at this time.

Event Description

On (b)(6) 2022, patient was prepped for a trial implant of the nalu spinal cord stimulator system.Sedation was administered and the physician attempted to place the implantable leads, however the patient's pre-existing condition of scoliosis and presence of scar tissue prevented the accurate placement of the system with the planned method.The procedure was aborted.

• 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: 17421655
• MDR Text Key: 320016146
• Report Number: 3015425075-2023-00128
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112208041725080410RK882
• 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: 07/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2023
• 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: RK882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other