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

Model Number 71005

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

There are no allegations of system or component failure, and no components were replaced during the revision procedure.The initial implant location of the ipg was in an anatomical location that the patient had difficulty accessing consistently.Moving the ipg to a more accessible location resolved the issue and no further complaints are on file for this patient.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023 after successfully completing a trial phase.The system was activated on (b)(6) 2023 and the patient reported difficulty with placing the external therapy discs due to the location of the implantable pulse generator (ipg), leading to communication issues between the ipg and therapy discs and thus intermittent therapy.A surgical revision was performed on (b)(6) 2023 to move the existing ipg to a location that was easier for the patient to access and place the therapy discs.

• 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: 17981378
• MDR Text Key: 326239913
• Report Number: 3015425075-2023-00251
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123071017260710
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other