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

Model Number 71005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 07/29/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, while in clinic, patient (b)(6) communicated she is experiencing soreness around the implanted lead anchors.X-rays revealed anchor sitting on spinous process.Current x-rays were compared to past x-rays revealing that the initial placement of the anchor was on the spinous process.Revision surgery was performed on (b)(6) 2020 to remove anchors.On (b)(6) 2020 the patient confirmed anchor soreness has beed relieved.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad, ca
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad, ca
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, ca ; 4482360
• MDR Report Key: 10443217
• MDR Text Key: 204057475
• Report Number: 3015425075-2020-00006
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537031101
• UDI-Public: 01008125370311011119011517200115
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2020
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR