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

Model Number	DTBA1D1
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Ventricular Tachycardia (2132); Dizziness (2194)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 1158t, lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator's (crt-d) supra ventricular tachycardia discriminator used to distinguish between rapid and gradual onset of fast ventricular rhythms may have inappropriately withheld high voltage therapy.The patient was thought to be in a true ventricular tachycardia as they were reportedly near syncope while at rest.Detection zones were adjusted and the feature was turned off.The device remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA¿ XT CRT-D
• 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: 10036757
• Report Number: 9614453-2020-01438
• Device Sequence Number: 3053296
• Product Code: NIK
• UDI-Device Identifier: 00763000059545
• UDI-Public: 00763000059545
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: 7001 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR