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

Model Number DTBA2D4

Device Problems Premature Discharge of Battery (1057); Electrical /Electronic Property Problem (1198)

Patient Problem Death (1802)

Event Date 09/30/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had a ventricular tachycardia (vt) that was initially treated with a burst of anti-tachycardia pacing that increased the ventricular tachycardia (vt) rate, then the atp during charge degenerated the ventricular tachycardia (vt) into a ventricular fibrillation (vf).The cardiac resynchronization therapy defibrillator (crt-d) exhibited high voltage problem despite being programmed to 35 joules (35j) energy level.The first shock delivered measured 7j and all the subsequent were 0j.The device was unable to deliver a full shock energy.Additionally, premature battery depletion was suspected.The device was inactivated and remains in the patient.Subsequently, the patient became deceased.

• Brand Name: VIVA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10809132
• MDR Text Key: 215286432
• Report Number: 9614453-2020-03608
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2016
• Device Model Number: DTBA2D4
• Device Catalogue Number: DTBA2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/09/2020
• Date Device Manufactured: 09/12/2014
• 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
• Treatment: 6935M62 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death
• Patient Age: 66 YR