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

Model Number 71005

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

The patient was receiving good pain relief prior to sustaining a fall and had no complaints around the nalu system.Migration of implanted components is a known inherent risk of implantable neuromodulation systems; however, this case appears to be directly related to external trauma.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023 to treat lower back and leg pain.Patient reported receiving good pain relief after activating the implant.Around (b)(6) 2023 the patient sustained a fall in which the implant site was directly struck, and the patient subsequently reported loss of therapy.Imaging confirmed the implantable pulse generator (ipg) and both leads had migrated after the fall.A surgical revision was performed on 13dec2023 in which the existing system was removed, and a new system was implanted back into the desired location to restore therapy.

• 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: 18508649
• MDR Text Key: 332873759
• Report Number: 3015425075-2024-00018
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123081817260818
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other