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

Model Number 72003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

Implanting physician elected to use his own coude needles rather than the surgical tools supplied in the nalu implant kit.There are no indications that the nalu surgical tools or any components of the nalu system failed or caused the inadvertent access of spinal fluid.Incident appears to be more related to the physician implanting technique.On (b)(6) 2023 the patient reported headache had dissipated and was doing well.

Event Description

On (b)(6) 2023, during the placement of a nalu spinal cord stimulator trial system, the implanting physician inadvertently punctured the dura, accessing spinal fluid.Physician elected to continue with the procedure and successfully placed one trial lead into the epidural space.Physician determined that the patient's preexisting scar tissue from previous surgeries made the placement of a second lead non-viable.Patient was programmed and reported high amounts of stimulation despite low amplitudes.Within two hours of the procedure patient reported a headache and described twitching in the lower extremities.Based on the patient reports of symptoms, the physician ended the trial and removed the implant on (b)(6) 2023.

• 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: 17187742
• MDR Text Key: 317720461
• Report Number: 3015425075-2023-00099
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112212061725120610UF550
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• 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: UF550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other