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 Arrhythmia (1721)

Event Date 01/06/2020

Event Type  Injury  

Event Description

It was reported that a patient was admitted into the hospital due to complaints of shortness of breath, which they were experiencing for one week and has been aggravated for two days, generalized weakness, and multiple episodes of vomiting.It was stated the patient has no history of similar events in the recent past.Patient is diagnosed to have complete heart block and the physician advised stopping vns and permanent pacemaker implantation (ppi).Vns was disabled.Information was later received that the subject was hospitalized with the symptoms of shortness of breath, vomiting, and fatigue however after evaluation of the case investigator determined this event to be ¿complete heart block¿.Complete heart block was determined to be unrelated to vns.Atrial fibrillation was determined to be possibly related to vns stimulation.No additional relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9668220
• MDR Text Key: 177760355
• Report Number: 1644487-2020-00178
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2020

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: Lay User/Patient
• Device Expiration Date: 01/01/2016
• Device Model Number: 7103
• Device Lot Number: 202820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other
• Patient Age: 53 YR