MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTBA1D4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130)
Date of Event	03/28/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Concomitant medical products: 4965-50 lead, implanted: (b)(6) 2018.A voluntary medwatch form 3500/3500b was received.Since code is not contained on that form, select fields ins have been populated by the manufacturer.User facility - (b)(6) hospital -(b)(6).Uf/importer report number: (b)(4).(b)(6).Date user facility became aware of event: unknown.Type of report: initial.Date of this report: (b)(6) 2018.Location where event occurred: hospital report sent to manufacturer: yes.Manufacturer name and address medtronic, (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant of the cardiac resynchronization therapy defibrillator (crt-d) system, defibrillation testing was unsuccessful.The patient then required external defibrillation.The right ventricular lead was repositioned and defibrillation testing was again unsuccessful.The patient was transferred to the intensive care unit.The patient continued to have ventricular fibrillation which was treated with medications and external defibrillation with plans to retest at a later date.However, the patient passed away two days later.The cause of death was requested and not available.

• Brand Name: VIVA XT
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 7814889
• Report Number: 9614453-2018-03009
• Device Sequence Number: 14040376
• Product Code: NIK
• UDI-Device Identifier: 00763000059668
• UDI-Public: 00763000059668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 04/14/2019
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: 63 YR
• Patient Weight: 31