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

Model Number 71005

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

Subject lead anchor was of an older design.The design has since been improved to address potential detachment of the lead.The redesigned anchor addresses the issue of the securement device coming apart from the overmold when securing the lead.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2022 with good pain relief at the time of activation.Patient subsequently reported loss of pain relief.Imaging confirmed migration of the implanted leads.Surgical revision was attempted on (b)(6) 2023 to reposition the existing leads.During the revision procedure it was noted that the leads had detached from the securement device components and were unable to be utilized for the revision.Replacement of components was not an option at the time of the procedure due to reimbursement status, so a full system explant was performed.

• 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: 17196288
• MDR Text Key: 317810540
• Report Number: 3015425075-2023-00093
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001120120317231203
• 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: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Device Lot Number: A02303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other