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

Model Number DTBA1D1

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

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 10/17/2014

Event Type  Injury  

Event Description

It was reported that approximately three weeks post routine device change-out the patient developed a pocket infection and systemic symptoms of endocarditis (fever, chills).Transesophageal echocardiography (tee) demonstrated vegetation on the leads consistent with endocarditis.The implantable cardioverter defibrillator (icd) and leads were explanted.During the explant procedure the patient became transiently hypotensive during removal of a lead.Tee imaging demonstrated trivial pericardial effusion.The system was replaced five days later.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where a similar model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Concomitant: 5076-52 lead 2010-(b)(6), 6947 lead 2010-(b)(6).(b)(4).

Manufacturer Narrative

No eval other description: analysis cannot be completed at this time due to pending litigation.Product event summary: the device was returned and analyzed.The device was returned but analysis could not be performed due to legal restrictions.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA¿ XT CRT-D
• 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
• MDR Report Key: 4315520
• MDR Text Key: 5135983
• Report Number: 3004209178-2014-23425
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2020

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: 08/28/2015
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; 12/16/2014; 12/16/2014; 01/27/2020
• Supplement Dates FDA Received: 02/10/2015; 09/15/2017; 09/15/2017; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 419478 LEAD; 419478 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00041 YR