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

Model Number 72003

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/02/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 the patient was implanted with a nalu spinal cord stimulator trial system to treat right sided lower back and upper leg pain.Procedure was normal with no complications reported and all intra-op testing satisfactory.Patient was moved to the post-anesthesia care unit for recovery from the procedure and to begin programming the system.Prior to beginning programming, the patient reported excessive pain in the left foot and leg.Patient was unable to be consoled with any treatment or plan of care in the recovery unit.Physician decided to completely remove the trial leads immediately.After explant, the patient reported having pain levels at a level where they were comfortable to leave the facility and follow up with the physician in the clinic the following day.

Manufacturer Narrative

Patient pain symptoms were immediately felt after implanting the trial leads and prior to activating the device.It is unlikely the symptoms were directly caused by the device itself and more likely caused by the placement of the leads, possibly on an unintended nerve root.

• 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: 17581175
• MDR Text Key: 321512964
• Report Number: 3015425075-2023-00199
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112301171726011710UF561
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2023
• 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: UF561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other