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 Inadequate Pain Relief (2388)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

During the (b)(6) 2023 procedure the patient had been adamant about the placement of the system, despite guidance from the nalu representative working with the case.The communication issues noted after the revision appear to be directly related to the placement of the implantable components in relation to the patient anatomy and not related to the functionality of the system or its components.There are no allegations of system or component failure or malfunction.The device remains implanted and thus is unavailable for any further investigation.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 to treat left shoulder pain.On (b)(6) 2023 the patient underwent a surgical revision to move the implant despite having good pain relief and against recommendations of medical staff (see mdr 3015425075-2023-00187).Immediately after the revision procedure, the patient was noted to have issues with communication between the implantable pulse generator (ipg) and the external therapy discs.Patient again reported receiving good therapy when the system was connected, however not receiving adequate pain relief due to the frequent disconnections when moving the left arm.On (b)(6) 2024 the firm was made aware that on (b)(6) 24 the patient underwent a surgical procedure to place a new ipg and lead.The existing ipg and lead were left implanted on the patient's lower chest wall.The new system was placed on the patient's left mid back/side area per the patient request.

• 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: 18919263
• MDR Text Key: 337844401
• Report Number: 3015425075-2024-00092
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122061617250616
• 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: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other