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

Model Number 71020

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Wound Dehiscence (1154)

Event Date 01/12/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 to treat lower back pain.The system was implanted in the lower back area to target the intercostal nerve.On (b)(6) 2024 the patient presented to the physician's clinic with concern of the implanted device protruding through the skin.Examination found that one of the surgical incision sites had dehisced and the implantable pulse generator (ipg) and implanted leads were exposed.Initial plan was to perform a surgical revision on (b)(6) 2024.Upon initiating the procedure the physician noted the possible presence of infection as well as poor tissue quality in the implant area and elected to fully explant the system at that time.No lab testing has been made available to the firm to confirm or rule out the presence of infection.

Manufacturer Narrative

There are no allegations of any failure or malfunction of the nalu system or its components.A suspected infection more than two months post implant is not likely to be caused by the device itself.Additionally, infection was suspected but not confirmed through lab testing.Per the physician, the quality of tissue at the implant site was not adequate to support the device.Inadequate tissue quality likely contributed to the surgical wound dehiscence and implant exposure.Malpositioning of the implant relative to the patient's body makeup appears to be the source of the event.

• 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 CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18682745
• MDR Text Key: 335072156
• Report Number: 3015425075-2024-00049
• Device Sequence Number: 1
• Product Code: GZF
• 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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other