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 05/24/2023

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 anadvertent access of spinal fluid.Incident appears to be more related to the physician implanting technique.

Event Description

On (b)(6)2023, during the placement of a nalu spinal cord stimulator trial system, the implanting physician inadvertently punctured the dura, causing a leak in spinal fluid.Trial leads were ultimately successfully placed into the epidural space, however the patient complained of a headache during post-op recovery and throughout the subsequent 7 days of the system trial.Trial leads were removed on (b)(6)2023 as per the standard trial plans.During the lead pull it was noted that the patient had a spinal fluid leak which required transfer of the patient to an acute facility for a blood patch.Patient did not move forward with implanting a permanent 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: 17190955
• MDR Text Key: 317746973
• Report Number: 3015425075-2023-00096
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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: 05/24/2023
• 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