MAUDE Adverse Event Report: MEDTRONIC, INC. VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, W/ CARDIAC RESYNCHRONIZATION

Model Number DTBA1D4

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2018

Event Type  malfunction  

Event Description

Patient underwent a medtronic aicd placement in late (b)(6) 2018.The leads and generator were placed without any issues noted.Ventricular fibrillation was induced, but the patient could not be defibrillated with the device despite several different configurations.The ventricular lead was disconnected and repositioned along the interventricular septum and actively fixed in position.The new ventricular stimulation threshold measured 1 volt with a lead resistance of 471 ohms and an r-wave amplitude of 7.6 mv.The ventricular lead was secured to the pectoralis muscle with 2-0 silk suture and a 2-0 silk pursestring suture was then placed around the leads at the entry site beneath the clavicle.The lead was connected to the defibrillator which was returned to the pocket.Ventricular fibrillation was induced, but the patient could not be defibrillated with the device and required external defibrillation.A decision was made to leave the device in place at the current time and retest at a later time.The patient tolerated the procedure with no known harm.

• Brand Name: VIVA¿ XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, W/ CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7746153
• MDR Text Key: 115989956
• Report Number: 7746153
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA