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

Model Number 71019

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/21/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023.When activating the implanted system in (b)(6) 2023 it was noted that the implantable pulse generator (ipg) had migrated within the pocket, causing communication issues between the ipg and the external therapy discs.A revision procedure was performed on (b)(6) 2023 to reposition the existing ipg to correct the communication issues.During the revision both implanted leads were replaced however the existing ipg remains in use with a corrected position.

Manufacturer Narrative

There are no reports of external trauma or other events that are likely to have led to the ipg migrating within the pocket.Migration is a known inherent risk of implantable neuromodulation systems.When repositioning the ipg there is a possibility that the handling of the system will damage the leads, thus both leads were replaced during the revision.

• 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: 17981377
• MDR Text Key: 326238787
• Report Number: 3015425075-2023-00252
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411123013117260131
• 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: 10/20/2023

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: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other