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

Model Number 71005

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

Patient Problem Headache (1880)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

Patient reportedly developed excessive scarring from the trial implant, making it challenging for the physician to access the appropriate space with the permanent system and requiring multiple attempts at implant.While it is unlikely that the nalu system malfunctioned in any way, it is likely that scarring and subsequent surgical technique during the implant procedure contributed to the patient complaint of headaches and the need for a blood patch.The patient perception was that the nalu system was potentially causing or contributing to the headaches being experienced and thus declined all attempts at activation and requested to have the system removed.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023 after a successful trial phase.Fluoroscopy imaging was used during the implant procedure and the implanted leads were placed in the epidural space in the vicinity of t8-t10.After implanting the permanent system, the patient complained of having persistent headaches.The nalu system remained inactive after the implant due to the persistent headache complaints.It was determined that the patient required a blood patch and the physician also chose to explant the nalu system at that time.A full system explant was performed 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: 18522164
• MDR Text Key: 332972851
• Report Number: 3015425075-2024-00026
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123013117260131
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other