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

Model Number	72003
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient has a history of other failed surgical interventions which the patient reports are due to scar tissue.Medical records for those failed attempts are not available to the nalu firm for review and confirmation.Patient is reported to have a congenitally narrow canal and likely significant spinal stenosis, making entry and placement of the nalu leads difficult and leading to the procedure being aborted.There are no reports from the implanting physician of any surgical tool failure or nalu system or component failure.
Event or Problem Description
On (b)(6) 2023 a surgical procedure was attempted and aborted.Patient was scheduled to receive the nalu spinal cord stimulator trial system implanted, however upon attempting to insert the leads the physician found he was unable to insert the leads past the t10 vertebra.Physician attempted entry at l1/2 and moved up to t12/l1 also with no success.Physician injected contrast dye into the epidural space and was not able to achieve any flow upward or laterally.Ultimately the physician elected to abort the procedure without placing the system.

• 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: 18416537
• Report Number: 3015425075-2023-00322
• Device Sequence Number: 20800225
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112211031725110310UF534
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/27/2023

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: 11/03/2025
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: UF534
• 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: 11/28/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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