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

Model Number	72003
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgical procedure was aborted and patient was deemed to not be a viable candidate for the nalu system at this time.
Event or Problem Description
On (b)(6) 2022, patient was prepped for a trial implant of the nalu spinal cord stimulator system.Sedation was administered and the physician attempted to place the implantable leads, however the patient's pre-existing condition of scoliosis and presence of scar tissue prevented the accurate placement of the system with the planned method.The procedure was aborted.

• 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: 17421655
• Report Number: 3015425075-2023-00128
• Device Sequence Number: 20578694
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112208041725080410RK882
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/29/2023

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: 08/04/2025
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: RK882
• 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: 12/21/2022
• Initial Report FDA Received Date: 07/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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