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 Inadequate Pain Relief (2388)

Event Date 03/20/2024

Event Type  Injury  

Event Description

Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2023 to treat lower back pain.Patient had successfully completed the initial trial phase and had reported pain levels on 1/10 during the trial.Permanent implant leads were placed in the same location as the trial, however patient later reported dissatisfaction with the system and lack of pain relief.Multiple troubleshooting and reprogramming sessions were conducted with the patient to address concerns but unable to satisfy the patient.On (b)(6) 2024 the firm was notified by the physician's office that the patient was requesting to have the system removed.On (b)(6) 2024 the firm was notified that a full system explant had been performed on (b)(6) 2024 with all components being discarded during the procedure.

Manufacturer Narrative

Per the physician, there are potentially underlying psychiatric issues that may be playing a role in the patient behavior.There is no indication of any system or component failure that is likely to have contributed to the patient dissatisfaction.During troubleshooting and reprogramming sessions the system appeared to have been functioning as expected.The firm was not notified of the scheduled procedure and thus was not present for the explant, all components were discarded and not available for further inspection and investigation.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19149785
• MDR Text Key: 340678188
• Report Number: 3015425075-2024-00136
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123083117260831
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2024
• 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: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other