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

Model Number	DTBA1D4
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's cardiac resynchronization therapy defibrillator (crt-d) was checked as they were found unresponsive.Review of the device data indicated a high right atrial (ra) lead threshold.It was noted the patient had also experienced a shock for fast ventricular tachycardia (vt) several months prior for what appeared to be atrial fibrillation (af) with rapid ventricular response.There were no clinical actions noted at this time.The ra lead and crt-d remain in use.No further patient complications have been reported as a result of this event.

• 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: 8384006
• Report Number: 9614453-2019-00629
• Device Sequence Number: 18929880
• Product Code: NIK
• UDI-Device Identifier: 00763000059668
• UDI-Public: 00763000059668
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5568-53 LEAD, 511211 LEAD, 6947M62 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR