MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	72003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/27/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The nalu trial system leads were implanted.The trial system does not include implantation of an implantable pulse generator (ipg) and the trial system did not get activated.There are no indications that the nalu system caused or contributed to the patient death.The patient passed all standard screenings prior to scheduling the procedure and there were no relevant pre-existing medical conditions disclosed to the firm.Exact cause of death is unknown to the firm.Death is a known inherent risk of sedation.
Event or Problem Description
On (b)(6) 2023 the patient was prepped for implant of a nalu peripheral nerve stimulator trial system, targeting the cluneal nerve to treat lower back pain.Patient was administered anesthesia for the procedure and placed in a prone position.The physician implanted the trial leads at the desired position.The procedure lasted approximately 10 minutes.After implanting the trial leads, the attending crna (certified registered nurse anesthetist) attempted to revive the patient after the procedure and discovered the patient had gone into cardiac arrest.Chest compressions were initiated.Emergency medical services arrived several minutes later and continued cpr.The patient was unable to be revived and was eventually pronounced dead.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18046309
• Report Number: 3015425075-2023-00263
• Device Sequence Number: 15310344
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: 01008125370336311123072117260721109455164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/31/2023

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: 07/21/2026
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: 09455164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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