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

Model Number DTBB1QQ

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

Patient Problems Infarction, Cerebral (1771); Death (1802); Diarrhea (1811); Endocarditis (1834); Fever (1858); Unspecified Infection (1930); Nausea (1970); Chills (2191)

Event Date 06/26/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported the patient presented to the clinic with a three week history of chills, fever, diarrhea and nausea.Lab word was performed and noted an elevated white blood cell count and blood cultures were positive for enterococcus faecalis.The patient was admitted to the hospital for intravenous antibiotics.A transesophageal echocardiogram was performed and vegetation was observed on the mechanical valve.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted and the patient had a redo aortic and mitral valve replacement.After the surgery the patient developed ischemic middle cerebral artery infarcts and died.The cause of death was indicated as prosthetic valve endocarditis.The patient was a participant in the post approval clinical surveillance product surveillance registry.

Manufacturer Narrative

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

Event Description

The patient was also diagnosed with bacteremia/septicemia.

• Brand Name: VIVA¿ QUAD S 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8913263
• MDR Text Key: 154999739
• Report Number: 3004209178-2019-16027
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530218
• UDI-Public: 00643169530218
• 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: 10/01/2019

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: 01/14/2018
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 10/01/2019
• Date Device Manufactured: 07/14/2016
• 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: 72 YR
• Patient Weight: 112