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

Model Number 71019

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/27/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 targeting the cluneal nerve to treat bilateral hip pain.Approximately one week after implant the patient reported difficulty with communication between the implantable pulse generator (ipg) and the external therapy discs.A surgical revision was performed (b)(6) 2023 to move the ipg from the lateral flank to a more medial position in order to correct the communication issues.No components were explanted or replaced during the procedure.

Manufacturer Narrative

The patient successfully completed a trial phase and wear study prior to implanting the nalu system.Intra-op and post-op testing of the system showed good connectivity.No imaging was performed prior to moving the device to confirm the placement of the ipg.It is possible the ipg migrated after implant or that the placement of the ipg was in an area of loose tissue, causing interference in communication as the patient was moved out of the prone position.

• 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: 18207867
• MDR Text Key: 328957990
• Report Number: 3015425075-2023-00291
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411123071017260710
• 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: 11/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2023
• 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: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other