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

Model Number 71007

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

During the explant several pieces of the system were fractured and unable to be retrieved.All explanted components were discarded by the facility at the time of explant and thus are not available for further testing by the firm.No imaging or other testing was performed prior to explant in order to assess system functionality.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 to treat shoulder and lower arm pain.Patient was reported as receiving pain relief from the implant and was last seen by a nalu representative for reprogramming in (b)(6) 2023.In (b)(6) 2023 the firm was made aware that the patient had contacted the surgery center requesting a system explant due to inadequate pain relief.Patient was offered troubleshooting and reprogramming and declined all offers.On (b)(6) 2023 a full system explant was performed per the patient request.

• 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: 18188707
• MDR Text Key: 328736122
• Report Number: 3015425075-2023-00286
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: 01008125370309991120022017210219
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other