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

Model Number	DTBB1QQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Death (1802); Diarrhea (1811); Endocarditis (1834); Fever (1858); Unspecified Infection (1930); Nausea (1970); Chills (2191)
Date of Event	06/26/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was also diagnosed with bacteremia/septicemia.

• Brand Name: VIVA¿ QUAD S CRT-D
• Common Device Name: 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: 8913263
• Report Number: 3004209178-2019-16027
• Device Sequence Number: 13803024
• Product Code: NIK
• UDI-Device Identifier: 00643169530218
• UDI-Public: 00643169530218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2018
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Weight: 112