MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D4

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

Patient Problems Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that several weeks after implant the patient developed an infection.The implantable cardioverter defibrillator (icd) and leads were explanted.The patient is enrolled in the adapt response clinical study.No further patient complications have been reported as a result of this event.(b)(6) 2015: additional information was received regarding this event.It was further reported that the patient awoke with fever, diaphoresis, and malaise.Patient was sent to emergency room (er) and found to have a pericardial effusion and was tachycardic.A chest tube was placed and drained a thick reddish exudate which was found to contain gram positive cocci.Patient was placed on intravenous antibiotics and underwent exploration of his thoracotomy incision and pacemaker pocket.This revealed infection in both locations.The device and epicardial leads were removed.Echocardiography showed resolved pericardial effusion but a large vegetation traversing the tricuspid valve and possibly adherent to one of the remaining endovascular leads.The patient underwent cardiopulmonary bypass, removal of the vegetative masses and endovascular leads, and open debridement of the infected areas.The patient was discharged home on iv antibiotics and the system was replaced on the right side approximately three months later.

Manufacturer Narrative

Concomitant medical products: product id 6996sq58, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product id 4968-60, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product id 6935m62, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014.(b)(4).(b)(6).

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4975515
• MDR Text Key: 6318738
• Report Number: 3004209178-2015-15478
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2015

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: 09/28/2015
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 08/05/2015
• Date Device Manufactured: 04/08/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00030 YR