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 11/01/2023

Event Type  Injury  

Manufacturer Narrative

Review of records found no previous communications or complaints from this patient related to the nalu system.The patient was offered troubleshooting prior to surgical intervention and patient declined.At the explant there was no visual indication of any device or component malfunction or migration, however there was no imaging or other testing performed prior to explant in order to confirm.The device was damaged during the explant procedure and thus is not in a condition that is conducive to testing by the firm.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator (pns) system on (b)(6) 2022 targeting the suprascapular nerve to treat shoulder pain.On (b)(6) 2023 the firm was notified by the surgical center that the patient was scheduled for a full system explant.Patient expressed that they did not feel like adequate pain relief was being achieved, patient wants to explant the pns system and pursue a spinal cord stimulator system.No further information was shared with the firm.A full system explant took place on (b)(6) 2023.

• 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: 18243746
• MDR Text Key: 329431297
• Report Number: 3015425075-2023-00295
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: 01008125370356041122053117250531
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other