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 10/26/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023 to treat bilateral lower back and leg pain.During the implant procedure the physician was able to access the dorsal column but was unsuccessful in placing a second lead.The procedure was concluded with only a single lead being implanted and ultimately the patient was unable to achieve full coverage of all pain areas with the single lead.On (b)(6) 2023 an additional surgical intervention was performed to place a second lead to increase coverage of all pain areas.During the procedure the physician also replaced the existing implantable pulse generator as a precaution due to the potential for damage of the component during the revision procedure.

Manufacturer Narrative

There are no allegations of any failure or malfunction of the nalu system or its components.The cause of the physician being unable to implant a second lead during the initial procedure is unclear, however it is unlikely related to the device itself and more likely related to the implanting technique used by the physician.The additional surgical intervention was performed to increase coverage of all pain areas.

• 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: 18207531
• MDR Text Key: 328958203
• Report Number: 3015425075-2023-00290
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123030217260302
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other