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

Model Number 71019

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The replaced components were damaged during the revision procedure and subsequently held by the medical facility.No devices are available for inspection and investigation by the firm, however there are no allegations of system or component failure.The lack of pain relief appears to be directly related to the pocket size and movement of the ipg within the pocket that was created during the initial implant.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023.The implantable pulse generator (ipg) was placed in a large pocket on the anterior thigh, placing the ipg beyond the optimal recommended depth and subsequently leading to issues connecting to the external therapy discs and thus causing inadequate pain relief for the patient.A surgical revision was performed on (b)(6) 2023 to place the ipg into a smaller pocket and thus restrict movement of the device, keeping it at the desired depth.During the procedure the ipg and implanted leads were damaged and thus all required replacement.

• 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: 18406883
• MDR Text Key: 331475173
• Report Number: 3015425075-2023-00324
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411121121517241215
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other