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

Model Number 71020

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

Xray imaging was taken at the local emergency department during the patient's pain event, however those images were not made available to the firm for evaluation of the placement of the nalu system components.After receiving medication, the patient reported continuing to receive pain relief from the nalu system.Based on the patient feedback of continuing to receive therapy, it appears that the nalu system was continuing to function appropriately and likely remained in place with minimal or no migration.Nalu staff were not present for the system explant as no notification was provided prior to the procedure.The explanted components were discarded by the medical facility during the procedure and thus unavailable for inspection and investigation of the device.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator on (b)(6) 2023 to treat lower back pain.Patient reported receiving pain relief therapy after the system was activated.Approximately three months after activation the patient was traveling and noted a sudden onset of pain, beginning in the arms and spreading across the entire body.Patient reports pain was severe enough to cause impaired mobility.Patient was taken by emergency medical services to the local emergency department for evaluation.Patient was given muscle relaxers and pain medication and advised to contact the primary physician.After being evaluated, the patient reports using the nalu system only for brief periods while doing extended periods of walking.The system provided some relief while activated, however the patient was concerned that the sudden pain would recur and requested to have the nalu system removed.A full system explant was performed on (b)(6) 2023.Nalu was made aware of the event and subsequent explant on (b)(6) 2023 when the patient reported the event to the firm.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: 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: 18116824
• MDR Text Key: 327881426
• Report Number: 3015425075-2023-00274
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122082517250825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other