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 08/30/2023

Event Type  Injury  

Manufacturer Narrative

There are no allegations of system or component failure and no reports of external trauma that may have contributed to the event.Migration of implanted components is a known inherent risk of implantable neuromodulation systems.

Event Description

On (b)(6) 2023 the patient was implanted with the nalu spinal cord stimulator and reported receiving pain relief therapy.Patient subsequently reported that the therapy had changed, and x-ray imaging confirmed that one of the implanted leads had migrated from its original location.Patient had a revision procedure performed on (b)(6) 2023 to reposition the migrated lead back to the desired location and re-anchor the lead in place.Patient also requested to have the implantable pulse generator (ipg) to be relocated during the procedure to make the location more accessible for placement of the external therapy discs.A new pocket was made during the procedure and the ipg was relocated per the patient request.After reconnecting all components, the system was tested and confirmed to be functioning as expected prior to closing the incision.No components were replaced, and no new implants were introduced during the procedure.

• 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: 17832744
• MDR Text Key: 324441045
• Report Number: 3015425075-2023-00228
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371122120517251205
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other