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

Model Number 71005

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

The patient is reported as having a high bmi and the ipg was initially implanted in a location with very soft adipose tissue.Communication issues began approximately three months after implant, indicating the initial implant placement was acceptable and the ipg migrated after the procedure.Troubleshooting found that the device was able to be connected, however would disconnect frequently when the patient was seated in certain positions.Ability to connect and provide therapy indicates the system was functioning and there was no malfunction of the system or its components.Migration is a known inherent risk of implantable neuromodulation systems.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023 targeting the thoracic nerve to treat lower back and leg pain.The implantable pulse generator (ipg) was placed in the lateral flank area and both intra-op and post-op testing was completed.Approximately three months after implant, the patient notified the firm of communication issues between the ipg and the external therapy discs and imaging confirmed the ipg had migrated within the pocket.Surgical revision was performed on (b)(6) 2023 to place a new ipg in a more superior and medial location and at a depth to avoid issues with weight fluctuation.Intra-op and post-op testing after the revision confirmed placement returned good connectivity.

• 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: 18363852
• MDR Text Key: 330989803
• Report Number: 3015425075-2023-00320
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371122111817251118
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other