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 02/28/2024

Event Type  Injury  

Manufacturer Narrative

During investigation of the loss of therapy, the patient noted that they had been involved in two automobile accidents and had been treated at an acute facility for neck and back injuries.The patient did not recall the exact dates, however the timing seems to correlate to the timing of therapy loss.It is likely that the trauma from the automobile accidents caused the migration of leads that had previously been in use for almost two years with no issues.No apparent failure or malfunction of the nalu system or its components, cause of migration in this case is external trauma.

Event Description

Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2022.In (b)(6) 2024 the patient notified a nalu representative that there was a loss of stimulation a "couple of months" prior.Xray imaging found that the implanted leads had migrated and were no longer targeting the desired location.A surgical revision was performed on (b)(6) 2024 to replace the migrated leads.During the procedure, handling of the implantable pulse generator (ipg) caused damage and caused the ipg to also require replacement.Original ipg location was on the right lower back.A new pocket was created for the new ipg on the left lower back, slightly left of the midline incision.New leads were placed in the t8-t9 vicinity.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18966294
• MDR Text Key: 338431180
• Report Number: 3015425075-2024-00098
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001122031017250310
• 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: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other