MAUDE Adverse Event Report: IPG MFG SWITZERLAND VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2QQ

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

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Date 09/22/2014

Event Type  Injury  

Event Description

It was reported that a possible pericardial effusion occurred with reported thoracic pain.An echocardiogram and x-ray were performed in which a small pericardial effusion was confirmed.Medication was administered and the system remains in use.The patient is a participant in the (b)(6) study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.This event occurred outside the us and patient information is not generally available due to confidentiality concerns.(b)(4).

• Brand Name: VIVA QUAD XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4677371
• MDR Text Key: 18291202
• Report Number: 9614453-2015-00918
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2015

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: 11/14/2015
• Device Model Number: DTBA2QQ
• Device Catalogue Number: DTBA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 04/10/2015
• Date Device Manufactured: 05/22/2014
• 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
• Treatment: 6935M62 LEAD, 459888 LEAD, 2088TC-46 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00046 YR