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 Sepsis (2067)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

There is no allegation of system or device failure.System was implanted (b)(6) 2023 and presence of sepsis was not noted until (b)(6) 2023.Timeline for symptoms seems to indicate that the device itself is not likely to have caused or contributed to the development of infection.It is likely that inadequate precautions with care of the surgical incision site allowed for bacteria to enter the bloodstream, however sufficient information is not present to draw a conclusive cause of the infection.Infection related to surgical incisions is a known inherent risk of invasive procedures.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023.On (b)(6) 2024 the firm became aware of the presence of infection at the surgical incision site and subsequent explant.Patient reports presenting to the local emergency department on (b)(6) 2023 due to surgical site appearing infected.Testing of blood confirmed sepsis and the patient was admitted to the acute facility for full system explant on the same day.Patient was treated with iv antibiotics while at the facility and released two days later.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18682744
• MDR Text Key: 335069234
• Report Number: 3015425075-2024-00048
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2024
• 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: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other