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

Model Number	72003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no indications of any malposition of the trial leads, no signs of wet tap during the procedure, no obvious issues with patient position during the procedure, and no indication of any system or component malfunction.Programs and settings used at the time of activation were intentionally low to allow the patient to recover and become acclimated to the therapy.No further information is available regarding the patient condition or suspected cause of the condition at the time of this incident reporting.
Event or Problem Description
On (b)(6) 2024 an 88 year old female patient was implanted with a nalu spinal cord stimulator trial system.The temporary trial leads were placed at t8-t9 area to target lower back pain.The procedure lasted approximately 20 minutes.While the patient was on the table being bandaged, she complained of discomfort in the neck area.Patient was assisted to a sitting position for the physician to finish the bandaging process.Upon standing, the patient reported some weakness in the lower extremities.The trial system was activated during post-op procedures, however the stimulation was run at very low settings to allow the patient to recover from the procedure and become accustomed to the therapy.Patient's daughter was present to take the patient home and stayed with her throughout the subsequent several days.On (b)(6) 2024 the patient contacted the physician to report ongoing discomfort/weakness in the lower extremities.Patient was seen in the physician's office and the physician attributed the symptoms reported to normal post-op discomfort.During the night on (b)(6) 2024 the patient reportedly got out of bed at some time during the night and sustained a fall in which she struck her head.Per the physician, the patient did not report the fall to anyone until (b)(6) 2024, at which time the patient informed her daughter of the incident.On (b)(6) 2024 the patient reported to the physician of generally not feeling well.The physician met with the patient on (b)(6) 2024 and assumed the malaise was due to the patient not tolerating the trial stimulator.Physician was unaware of the head trauma at that time.Trial leads were pulled on (b)(6) 2024 and patient was sent home with her daughter.On (b)(6) 2024, the nalu rep following this case reached out to the patient's daughter to inquire on how she was doing after removing the trial leads.Daughter informed the rep that the patient was at an acute facility, in a coma, and on life support.Date of admission is unknown and current patient status is unknown at the time of reporting.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19348750
• Report Number: 3015425075-2024-00187
• Device Sequence Number: 7413077
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112310271726102710CWK330
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/19/2024

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 Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: CWK330
• 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: 04/25/2024
• Initial Report FDA Received Date: 05/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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