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

Model Number 72003

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/26/2022

Event Type  Injury  

Event Description

Patient was implanted with the nalu spinal cord stimulator trial system on (b)(6) 2022.While in post-op recover it was discovered that the patient was not receiving adequate coverage of the target pain area and it was determined that during the implant procedure one of the implanted leads had been pulled out of the desired position.Patient was returned to the operating room immediately to re-open the incision and reposition the lead.

Manufacturer Narrative

Re-positioning of the lead was successful and the patient was able to complete the trial phase and move on to permanent implant, reporting great relief and happy with the nalu system.

• 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: 17443695
• MDR Text Key: 320232498
• Report Number: 3015425075-2023-00147
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112208021725080210RK881
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: RK881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other