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

Model Number 71020

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 to treat low back pain.In december 2023 the patient notified the firm that an explant is being requested.Patient expressed frustration with the nalu system but did not provide a specific event that triggered the frustration.Patient had been implanted for less than a year before requesting explant.No further information was provided to the firm.On 21feb2024 the firm became aware that the patient had undergone surgical explant of the nalu system on (b)(6) 2024.

Manufacturer Narrative

Review of records found that this patient had reported multiple issues with the external devices which required the components to be replaced.Patient had also undergone a surgical revision in march 2023 due to migration of the implantable pulse generator (see mdr 3015425075-2023-00051).Previous complaints were thought to have been resolved and the patient had not communicated any further issues for aproximately eight months prior to requesting an explant.The patient did not provide any additional information as to any specific event that caused the explant request.The firm was not made aware and was not present for the explant procedure to evaluate the system.The explanted components were discarded at the facility and are not available for further inspection and investigation.

• 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 CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18952007
• MDR Text Key: 338265833
• Report Number: 3015425075-2024-00094
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122052717250527
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other