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

Model Number 71005

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/26/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2020.In (b)(6) 2023 the patient met with a nalu representative for a standard reprogramming session, however the patient was unable to feel paresthesia in the area of desired coverage and was unable to obtain sufficient pain relief.Imaging was requested to verify position and placement of the implanted devices.After the reprogramming session the patient became unresponsive to communication from nalu personnel and no imaging was completed.In december 2023 the firm was notified that the patient was scheduled for surgical intervention, however no reason was provided and patient remained unresponsive to communication.A nalu representative met with the patient on (b)(6) 2024 at which time the patient expressed no longer wishing to utilize an external device.On (b)(6) 2024 the nalu system was explanted and replaced with a fully implantable competitor system.

Manufacturer Narrative

Patient had the nalu system in place for more than two years before being explanted and a review of records found no history of any previous incidents or complaints related to this patient.Imaging was not completed prior to the system being explanted, unable to confirm the placement of the implanted components, unable to confirm presence or absence of damage to the components.Patient became unresponsive to communication from the firm.The firm is unable to fully establish the cause of the loss of pain relief due to lack of evidence and poor communication.

• 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: 18774933
• MDR Text Key: 336188325
• Report Number: 3015425075-2024-00064
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other