MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number 71005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

The patient successfully completed a trial and wear experience prior to the permanent device implant.The original implant location was in a location on the lower back with skin folds, which contributed to the patient dissatisfaction over time.Patient's physical anatomy appears to be a significant contributing factor in the dissatisfaction with the location of the device.Additionally, the patient spends a significant amount of time standing or walking, is experiencing increasing back issues, and is anticipating surgical intervention for those pre-existing conditions.A new ipg was placed in a slightly higher location the back with less tissue and flatter skin and the patient reports improved therapy after the revision.

Event Description

The patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023.Several months after being implanted, the patient expressed dissatisfaction with the location of the implantable pulse generator (ipg) due to discomfort and increasing communication issues between the ipg and the external therapy discs.Patient requested to have the ipg moved.Surgical revision took place on (b)(6) 2023.Initial plan was to move the existing device to the desired location, however during the procedure the ipg was damaged and required replacement.The existing leads remained in place and in use.The procedure took place on (b)(6) 2023, however the firm did not become aware of the event until (b)(6) 2023.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18145887
• MDR Text Key: 328223369
• Report Number: 3015425075-2023-00279
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371122110717251107
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other