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 11/08/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2022 to treat lower back pain.Approximately one year after implant, the patient reported communication issues between the implantable pulse generator (ipg) and the external therapy discs.The ipg was determined to have migrated within the pocket, causing poor communication.Surgical revision was performed to reposition the ipg, however during the procedure the ipg was damaged and required replacement.The implanted leads remained in place.

Manufacturer Narrative

Review of records found no previous complaints or incidents for this patient relating to communication issues.No reports were found of external trauma or event that may have caused or contributed to the migration of the ipg.Migration of implanted components is a known inherent risk of implantable neuromodulation systems.

• 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: 18280209
• MDR Text Key: 329889253
• Report Number: 3015425075-2023-00310
• Device Sequence Number: 1
• Product Code: GZB
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other