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 Cardiopulmonary Arrest (1765); Death (1802); Encephalopathy (1833); Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Lethargy (2560)

Event Date 02/07/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2007.419688 lead, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted with hypotension in an altered mental state due to subacute infective endocarditis and bacteremia.The patient was treated with intravenous antibiotics and was discharged to a transitional care unit (tcu).The patient was later readmitted from the tcu due to lethargy and unresponsiveness due to multifactorial metabolic encephalopathy.The patient's family decided to transition the patient to comfort care only and had the cardiac resynchronization therapy defibrillator (crt-d) system detections and therapies programmed off.The patient expired the following day with the primary cause of death being reported as cardiopulmonary arrest.The patient was a participant in the post approval clinical surveillance product surveillance registry.No further information was reported.

Manufacturer Narrative

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

Event Description

Blood cultures showed enterococcus faecalis and a transesophageal echocardiogram (tee) showed vegetation on the tricuspid valve.The physician felt that the system should have been explanted.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8456217
• MDR Text Key: 140004764
• Report Number: 3004209178-2019-06144
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007239
• UDI-Public: 00643169007239
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2015
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• Date Device Manufactured: 03/20/2014
• 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: 6947M55 LEAD, 5867-3M ADAPTOR
• Patient Outcome(s): Death
• Patient Age: 85 YR