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

Model Number	72003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3015425075-2023-00199
• Device Sequence Number: 21072179
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112301171726011710UF561
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown