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

Model Number	DTBA1QQ
Medical Device Problem Codes	High impedance (1291); Mechanical Problem (1384); Misconnection (1399); Pacing Problem (1439)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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 post implant of the cardiac resynchronization therapy defibrillator (crt-d) deice, there was failure of pacing and capture.Interrogation showed there was increased impedance on the right ventricular (rv), right atrial (ra) and left ventricular (lv) leads.During device revision, the leads were disconnected from the device and every lead was checked alone and all leads measured normally.The same device was reconnected to the leads and it was found there was difficulty connecting lv lead to the connector port and the screw could not be fixed properly.There was no other explanation for this problem except technical problem in the head connector of the device.The device was explanted and replaced and all parameters were excellent.No patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD 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: 8482180
• Report Number: 9614453-2019-01110
• Device Sequence Number: 1761526
• Product Code: NIK
• UDI-Device Identifier: 00763000059651
• UDI-Public: 00763000059651
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/04/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR