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

Model Number 71020

Device Problem Malposition of Device (2616)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022.After activation the patient reported persistent communication issues between the implantable pulse generator (ipg) and the external therapy disc that were unable to resolved through conservative troubleshooting with nalu tech support and onsite representatives.On (b)(6) 2023 the physician performed a surgical procedure to relocate the ipg to a more superficial location in order to improve communication with the therapy disc.No components were explanted or replaced during the procedure and the patient reports no further communication issues.

Manufacturer Narrative

There are no allegations of system or component failure.All components remain in use with good results for the patient.

• 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: 17282901
• MDR Text Key: 318644046
• Report Number: 3015425075-2023-00103
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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
• Device Lot Number: A04190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other