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

Model Number DTBA1QQ, 439888, 407652, 6947M62

Device Problem Connection Problem (2900)

Patient Problems Dyspnea (1816); Vomiting (2144); Loss of consciousness (2418)

Event Date 07/04/2018

Event Type  Injury  

Event Description

At approx 1:00 am, i started having shortness of breath.As my husband and i prepared to go to the er.I lost consciousness, and my husband called 911.While waiting for the arrival of the ambulance, i lost consciousness again.While in the ambulance on our way to the hospital, i began vomiting.While in the er i continued a cycle of losing consciousness and vomiting just about every 5-10 minutes.The hospital was unable to get an accurate read on my device which resulted in them calling the medtronic specialist for assistance.Upon his arrival (after being in the er for approx 2.5 hrs at this point), he was able to increase the voltage on my device after he was unable to get an accurate read himself.It was then determined that i would need more assistance as to why the device wasn't working properly.I was transported to (b)(6), where it was determined that the lead connected to the bottom of my heart was faulty.The drs felt that it would be best to replace the entire device with a completely different mfr instead of just replacing the wire.I remained in the hospital for an add'l 2 days before being released to go home to continue recovery.

• Brand Name: VIVA QUAD XT CRT-D DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 7709801
• MDR Text Key: 114813754
• Report Number: MW5078495
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/12/2018

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 Model Number: DTBA1QQ, 439888, 407652, 6947M62
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 71 YR
• Patient Weight: 70