MAUDE Adverse Event Report: CYBERONICS - HOUSTON VITARIA GEN MODEL 7103; GENERATOR

Model Number 7103

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

Patient Problem Ecchymosis (1818)

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported that patient was experiencing adverse event of postoperative hematoma.Event is not reported as an serious adverse event.Event is definitely related to implant.Outcome is recovered/resolved.Action was taken in the form of non-drug treatment.It was reported that hematoma developed at the level of the laterocervical incision that required surgical evacuation the second day postoperatively.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not required as the cause is known and device evalution would add no value to the investigation.

• Brand Name: VITARIA GEN MODEL 7103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14879115
• MDR Text Key: 295114590
• Report Number: 1644487-2022-00783
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2020
• Device Model Number: 7103
• Device Lot Number: 204500
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2018
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male