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

Model Number 72007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

No components were replaced during the surgical procedure, indicating that there is no failure or malfunction of the nalu system or any of its components.Need for surgical intervention is directly related to the patient having a change of physical condition.

Event Description

On (b)(6) 2023 the patient was implanted with a nalu peripheral nerve stimulator system to treat knee pain.After being implanted the patient began a weight loss regimen and lost a significant amount of weight, including subcutaneous fatty tissue at the location where the nalu device was implanted.Due to the loss of tissue, the implanted lead coils became visible on the surface of the skin and clearly too superficial.On (b)(6) 2024 a surgical revision was performed to create a deeper pocket for the lead coil.

• 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: 19056401
• MDR Text Key: 339549889
• Report Number: 3015425075-2024-00120
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036342
• UDI-Public: 0100812537036342112303091726030910UW925
• 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: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 72007
• Device Catalogue Number: 72007
• Device Lot Number: UW925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other