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); Sepsis (2067); Thrombosis (2100)

Event Date 08/31/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 419588 lead, implanted: (b)(6) 2008; 6945-65 lead, implanted: (b)(6) 2001.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to sepsis.After the system extraction, the patient was extubated and subsequently lost consciousness.Cardiopulmonary resuscitation (cpr) and medication was started, however the patient later passed away.A transesophageal echocardiogram showed no effusion, and per the physician the cause of death was likely a thrombus.

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.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.

• 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: 6883060
• MDR Text Key: 86975881
• Report Number: 3004209178-2017-19813
• 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,Followup,Followup
• Report Date: 09/05/2017

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: 05/28/2016
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 09/11/2017; 10/11/2017
• Supplement Dates FDA Received: 10/06/2017; 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 87 YR