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

Model Number DTBA1D1

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

Patient Problems Death (1802); Dehydration (1807); Endocarditis (1834); Fever (1858); Staphylococcus Aureus (2058); Sepsis (2067); Heart Failure (2206)

Event Date 02/11/2018

Event Type  Death  

Manufacturer Narrative

Continuation of medical devices: 4543 lead implanted (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted in heart failure for possible treatment of endocarditis and bacteria in the blood.The patient was in an altered mental status with fever and dehydration and was found to have bacteremia due to staphylococcus and gram positive cocci sepsis.Palliative care was decided upon due to the patient¿s end-stage cardiomyopathy and non-candidacy for explantation, transesophageal echocardiogram (tee) or inotropic support.Intravenous antibiotics were administered.The patient was released the following week to home hospice care with tachyarrhythmia detections turned off on the cardiac resynchronization therapy defibrillator (crt-d) system.The patient died of sepsis three days post-discharge.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.No further information was reported.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7427232
• MDR Text Key: 105364624
• Report Number: 3004209178-2018-07941
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007246
• UDI-Public: 00643169007246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2017
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2018
• Date Device Manufactured: 08/06/2015
• 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): Death
• Patient Age: 75 YR
• Patient Weight: 79