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

Model Number 71005

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the nalu quality department was made aware of a procedure in which a patient underwent a full system replacement.It was discovered on or around (b)(6) 2022 that the patient's implanted leads had migrated.The migration of leads required surgical intervention.System was explanted and replacement was performed on (b)(6) 2022 and was reported to nalu's quality group on (b)(6) 2022.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; carlsbad 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: 15115302
• MDR Text Key: 296755105
• Report Number: 3015425075-2022-00046
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371121051217240512
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other