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 11/10/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 targeting the superior genicular nerve to treat knee pain.During a post-op visit on (b)(6) 2023 there was significant swelling noted and the implantable pulse generator (ipg) was unable to be palpated.A nalu representative worked with the patient to attempt programming during that visit but was unsuccessful due to the swelling and depth of the ipg.Patient was instructed to return in one week to attempt programming after allowing the post-op swelling to further subside.On (b)(6) 2023 the patient was see again for programming with minimal success due to connectivity issues between the ipg and the external therapy discs.On (b)(6) 2023 a surgical revision was performed to move the ipg to a more superficial location.No components were replaced or explanted during the procedure.Patient was seen on (b)(6) 2023 for programming and education and was able to have the system activated and all pain areas covered.

Manufacturer Narrative

There is no indication of any nalu system or component failure or malfunction, as evidenced by all components remaining in use after the system was repositioned.The connectivity issues noted were a direct result of the nalu system being implanted beyond the recommended depth.

• 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: 18280203
• MDR Text Key: 329889352
• Report Number: 3015425075-2023-00303
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other