MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

Veran is submitting this mdr as part of an overall retrospective review in response to an fda form 483 that was issued to the firm as of january 2019.

Event Description

System performed as intended; no malfunction.Patient had a pneumothorax.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: SPIN THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: christine hardin ; 1908 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 9401567
• MDR Text Key: 168811190
• Report Number: 3007222345-2019-00017
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other