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

Model Number 72002

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

Although patient infection was reported, patient infection could not be confirmed.

Event Description

Patient's device was explanted due to suspected infection at midline incision.

• Brand Name: NAUL 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 avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 13726688
• MDR Text Key: 287141107
• Report Number: 3015425075-2022-00009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033624
• UDI-Public: 0100812537033624112102241724022410NJ811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

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: 02/24/2024
• Device Model Number: 72002
• Device Catalogue Number: 72002
• Device Lot Number: NJ811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2021
• 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