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

Model Number 71005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 08/21/2023

Event Type  Injury  

Event Description

Patient successfully completed a wear trial with the nalu spinal cord stimulator system on (b)(6) 2023 and had a permanent system implanted on (b)(6) 2023 to replace an existing competitor system.The nalu system was the third system to be implanted for this patient to treat the same area of pain and was implanted in the same anatomical location as the previous systems.Patient had the nalu system activated approximately two weeks after implant, during a post-op clinic visit, and reported receiving stimulation and pain therapy at that time.On (b)(6) 2023 the patient contacted a local nalu clinical specialist to report discomfort at the incision site and a "jolting sensation" that occurred occasionally regardless of the nalu system being on or off.Patient also reported discontent with having any kind of implanted stimulator and being able to palpate the implanted anchors.Patient reported refusal to wear or use the nalu system after the initial activation and requested explant.System explant was performed on (b)(6) 2023 with no reported complications.

Manufacturer Narrative

The nalu system was the third implantable neuromodulation system used by this patient, with all three systems being from different manufacturers.Patient reported receiving therapy upon initial activation, however, was displeased with being able to palpate the system under the skin and expressed not wanting to have anything implanted.It is unlikely that the patient complaint of a "jolting sensation" was related to the nalu system as the patient stated this occurred even with the system turned off.The explanted device was retained by the medical facility and is unavailable for investigation by nalu to verify no malfunction.Physician reported that this case is likely psychosomatic in nature and unrelated to the actual device or it's components.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: 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: 17761541
• MDR Text Key: 323580787
• Report Number: 3015425075-2023-00219
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371122102117251021
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other